Import Alert 80-06

(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).

Import Alert # 80-06
Published Date: 08/25/2020
Type: DWPE

Import Alert Name:

"Detention Without Physical Examination of Medical Devices with False or Misleading Labeling"

Reason for Alert:

Note: Revision of this Import Alert dated 08/25/2020 updates the Import Alert Name, the subtype to “Firm Alert”, the reason for the alert, the Guidance section to reflect current terminology and to add guidance, updates the contact information, and product description. Changes are bracketed by asterisks (***).

***The Food and Drug Administration has warned and/or taken action against a number of companies that have made improper claims about their products’ intended use. Some may carry significant health risks.

Section 502(a) declares that a drug or device is misbranded if its labeling proves false or misleading in any particular. Section 201(n) states that if an article is alleged to be misbranded because the labeling or advertising is misleading. Then, in determining whether the labeling or advertising is misleading, there shall be taken into account (among other things) not only representations made or suggested by statement, word, design, device, or any combination thereof, but also the extent to which the labeling or advertising fails to reveal facts material in the light of such representations or material with respect to consequences which may result from the use of the article to which the labeling or advertising relates under the conditions of use prescribed in the labeling or advertising thereof or under such conditions of use as are customary or usual.***

Guidance:

*** Divisions may detain, without physical examination, shipments of the products identified on the Red List of this Alert.

A recommendation for addition to detention without physical examination and background information should be forwarded to DIO. DIO will coordinate a review of all recommendations for addition to detention without physical examination with CDRH Imports and Registration and Listing Team.***

The following devices are excluded from coverage under this Import Alert and any investigation of such devices should not be included:

a. Devices intended exclusively for use upon animals (non-human), check with the Center for Veterinary Medicine.

b. Prescription devices, which are being marketed as such.

***Removal from Detention without Physical Examination (REMOVE FROM RED LIST):
In order to remove a firm's product from the Red List, information should be provided to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation. The purpose of this is so that the Agency will have confidence that future shipments/entries will be in compliance with the Federal Food Drug and Cosmetic Act (FD&C Act). For further guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention without Physical Examination (DWPE)."

If a firm and/or a representative thereof would like to petition for removal from detention without physical examination under this Import Alert, all relevant information supporting the request should be forwarded to the following address:

Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857

Or, be sent via email to: Importalerts2@fda.hhs.gov

DIO will coordinate the evaluation of a request for removal from detention without physical examination with CDRH Imports and Registration and Listing Team.

Questions involving import operations should be addressed to ORA/DIO (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov

Questions or issues involving OASIS or PREDICT screening should be addressed to ORA/DSS/Import Systems Branch at oraoismdssimpcomplsysbr@fda.hhs.gov

Questions concerning these types of devices or other compliance issues, should be addressed to the CDRH Imports and Registration & Listing Team via email: CDRH Import Mailbox cdrhimport@fda.hhs.gov ***

Product Description:

**All medical devices***

Charge:

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a device which is misbranded in that its labeling is false or misleading." [Misbranding, Section 502(a)]

OASIS charge code – FALSE

List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)


AUSTRALIA


Q-Tech Laboratories
Date Published : 09/16/2009
Level 1\453 Ruthven St , Carrington, QLD AUSTRALIA
84 - - - -- Neurological
Date Published: 09/16/2009

Desc: Bio-electric field enhancement unit (EEFE)
Notes: Relief of arthritis; muscular aches & pains allergies; incontinence; etc. 8/30/2000


CANADA


Europe Cosmetiques
Date Published : 09/16/2009
3471 Bou Thimens , Saint-Laurent, QC CANADA
77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009

Desc: Auricular candles with Otoska oil
Notes: Effective in treatment of ear wax build up; hearing problems; sinus congestion; frequent migraines and earaches. 4/3/96

Kencayd Consulting (aka Candela Earcandles)
Date Published : 09/16/2009
555 Ridley Drive , Victoria, BC CANADA
77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009

Desc: Ear candles
Notes: Promotes better hearing; better lymphatic circulation; pressure regulation; etc. 2/5/1997

Nature Beaute Sante
Date Published : 09/16/2009
7500 Mountain Heights Ave , Montreal, QC CANADA
77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009

Desc: Auricular candles with oil - Oil manufacturer
Notes: Effective in treatment of ear wax build up; hearing problems; sinus congestion; frequent migraines and earaches. 4/3/96

Robert McFarland dba Radionics Institute
Date Published : 09/16/2009
411-75 Eastdale Avenue , Toronto, ON CANADA
80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009

Notes: Metal circular bowl entitled the "SUPERCONDUCTOR" Any therapeutic claims including but not limited to diabetes, leukemia,meningitis, multiple sclerosis, and tuberculosis.

S A Wilson
Date Published : 09/16/2009
2891 Regional Road # 20 Unit # 2 , Bowmanville, Ontario, Ontario CANADA
78 F - - CE Kit, Enema, (For Cleaning Purpose)
Date Published: 09/16/2009

Notes: Liver detoxification; pancreatic cancer detoxification; relief from migraines                           

Superior Ear Candles, DIvision of J&P Holdings
Date Published : 09/16/2009
P.O. Box 137 , Parson, BC CANADA
77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009

Desc: Ear candles
Notes: Promotes better hearing; better lymphatic circulation; pressure regulation; etc. 2/5/1997

The Quantum Alliance Corporate Headquarters
Date Published : 09/16/2009
27 Cougar Ridge View SW , Calgary, Alberta CANADA
84 H - - CC Device, Biofeedback
Date Published: 12/02/2019

Desc: Electro Physiological Feedback Xrroid (EPFX) software (CLASP32 MASTER Program) and accessories
Notes: The firm's website contains statements which represent or suggest that the device is adequate and effective. The representations or suggestions are false or misleading or otherwise contrary to fact because the device is not adequate or effective for stated purposes; 09/24/08


CHINA


Heze Healthicon Medical Instruments Co Ltd
Date Published : 09/16/2009
12 Jiefang Main Street , Heze, Shandong CHINA
79 G - - AW Suture, Nonabsorbable, Synthetic, Polypropylene
Date Published: 09/16/2009

Desc: Prolene sutures
Notes: Counterfeit- Package labeling may indicate manufactured by Ethicon 11/8/2005

High Hope Intl Group
Date Published : 09/16/2009
91 Baixia Road , Nanjing, CHINA
79 G - - AW Suture, Nonabsorbable, Synthetic, Polypropylene
Date Published: 09/16/2009

Desc: Prolene sutures
Notes: Counterfeit- Package labeling may indicate manufactured by Ethicon 11/8/2005

Shanghai Electronics Componen
Date Published : 09/16/2009
816 Yan An Road , Shanghai, CHINA
80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009

Desc: Ceramic magnetic cup
Notes: 5/16/1994

Shenzhen Supernatural Hand Electronic Co., Ltd.
Date Published : 09/16/2009
Block C Room 2001-2006 , Ren Min South Rd , Shenzhen, Guangdong CHINA
89 I - - SA Massager, Therapeutic, Electric
Date Published: 12/10/2019

Desc: Supernatural Hand Super Low Frequency Massager NM-166
Notes: 5/9/1997

Tianjin Bei Dou Iron Plastic Enterprise Co Ltd
Date Published : 09/16/2009
No FU 5 Dong Lin Street , Harbin Magnetizer Manufacturing Factory , Harbin, Dong Li District CHINA
80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009

Desc: Magnietic drinking cup
Notes: 3/29/1994

Youda Electronics (Shenzhen) Co., Ltd.
Date Published : 01/29/2010
Xiangxingganzel Industry Zone , Shajing Baoan Area , Shenzhen, Guang Dong, CHINA
79 G - - EX Powered laser surgical instruments
Date Published: 01/29/2010

Desc: Revitalizes and rejuvenates the skin
Notes: Claims

95 L - - 22 Laser Product for Non-Medical Use
Date Published: 01/29/2010

Desc: Laser Light Applicator
Notes: Claims; Revitalizes and rejuvenates the skin


HONG KONG


Ace Integrated Solutions Ltd
Date Published : 01/29/2010
Unit A 5/F Yu Fung Comm Centre , Wanchai, HONG KONG
79 G - - EX Powered laser surgical instruments
Date Published: 01/29/2010

Desc: Laser Light Applicator
Notes: Claims; Revitalizes and rejuvenates the skin.

95 L - - 22 Laser Product for Non-Medical Use
Date Published: 01/29/2010

Desc: Laser Light Applicator
Notes: Claims; Revitalizes and rejuvenates the skin


HUNGARY


MANDELAY KFT
Date Published : 09/16/2009
Huba Utca 25-2 , Tokol, Pest HUNGARY
84 H - - CC Device, Biofeedback
Date Published: 09/16/2009

Desc: Electro physiological feedback Xrroid (EPFX); Quantum Xrroid Consciousness Interface (QXCI) and accessories; Scientific Consciousness Interface Operations System (SCIO);Virtual Reality Imagery (VRI); Ascultacardiogram; CLASP 32 Master Program 1 CD; CLASP 32 Master Program 2 CD; Living Information Forms Energy (L.I.F.E) System
Notes: "bio-energetic medicine" for the treatment of disease or adverse medical conditions.The EPFX has a premarket notification for therapeutic biofeedback to control stress and to teach a patient to relax. The EPFX was not given marketing clearance for evoked potential biofeedback technology; to read the client¿s subtle energy fields; for electro-dermal screening; or for measuring the physical; mental; and emotional levels. 1/4/2008

84 H - - CC Device, Biofeedback
Date Published: 09/16/2009


INDIA


Globe Traders
Date Published : 09/16/2009
15 Dr. V9 Gamomi Marg , Mumbai, INDIA
79 F - - TL Mesh, Surgical, Polymeric
Date Published: 09/16/2009

Desc: Ethicon Prolene Mesh II
Notes: Counterfeit-Packaging may show ethicon logo printed in Copper plate rather than Helvetica & pouch lacks single piece of adhesive backing 2/10/2004


KOREA, REPUBLIC OF (SOUTH)


Bridget Lifescience Co Ltd
Date Published : 11/22/2011
12TH FL., SHINWOONG TOWER , 719 YEOKSAM2-DONG , GANGNAM-GU, SEOUL TEUGBYEOLSI KOREA, REPUBLIC OF (SOUTH)
76 L - - YB Laser, Dental
Date Published: 11/22/2011

Desc: Laser Toothbrush
Notes: class II

M&H Co
Date Published : 11/22/2011
436-16 Changgokri , Gyeonggi-do, KOREA, REPUBLIC OF (SOUTH)
76 L - - YB Laser, Dental
Date Published: 11/22/2011

Desc: Laser Toothbrush
Notes: class II


PAKISTAN


Surgeon Surgical (Pvt) Ltd.
Date Published : 05/24/2011
Small Industrial Estate , Sialkot, Punjab, PAKISTAN
73 - - - -- Anesthesiology
Date Published: 05/24/2011

Notes: *All devices                                                                                                                                                                                                                                                                                                                                                                                                                                                     

74 - - - -- Cardiovascular
Date Published: 05/24/2011

Notes: *All devices                                                                                                                                                                                                                                                                                                                                                                                                                                                     

76 - - - -- Dental
Date Published: 05/24/2011

Notes: *All devices                                                                                                                                                                                                                                                                                                                                                                                                                                                     

77 - - - -- Ear,Nose And Throat
Date Published: 05/24/2011

Notes: *All devices                                                                                                                                                                                                                                                                                                                                                                                                                                                     

78 - - - -- Gastroenterological & Urological
Date Published: 05/24/2011

Notes: *All devices                                                                                                                                                                                                                                                                                                                                                                                                                                                     

79 - - - -- General & Plastic Surgery
Date Published: 05/24/2011

Notes: *All devices                                                                                                                                                                                                                                                                                                                                                                                                                                                     

80 - - - -- General Hospital/Personal Use
Date Published: 05/24/2011

Notes: *All devices                                                                                                                                                                                                                                                                                                                                                                                                                                                     

84 - - - -- Neurological
Date Published: 05/24/2011

Notes: *All devices                                                                                                                                                                                                                                                                                                                                                                                                                                                     

85 - - - -- Obstetrical & Gynecological
Date Published: 05/24/2011

Notes: *All devices                                                                                                                                                                                                                                                                                                                                                                                                                                                     

86 - - - -- Ophthalmic
Date Published: 05/24/2011

Notes: *All devices                                                                                                                                                                                                                                                                                                                                                                                                                                                     

87 - - - -- Orthopedic
Date Published: 05/24/2011

Notes: *All devices                                                                                                                                                                                                                                                                                                                                                                                                                                                     

89 - - - -- Physical Medicine
Date Published: 05/24/2011

Notes: *All devices                                                                                                                                                                                                                                                                                                                                                                                                                                                     

90 - - - -- Radiological
Date Published: 05/24/2011

Notes: *All devices                                                                                                                                                                                                                                                                                                                                                                                                                                                     


RUSSIA


Alta Company
Date Published : 09/16/2009
Ismailovskow sh71 , Hotel Izmailovskow Delta , Moscow, RUSSIA
73 - - - -- Anesthesiology
Date Published: 09/16/2009

Notes: Automatic Electronic Stimulator a.k.a: Autonomous Electronic Stimulator AES, Life Saver (a small capsule swallowing, inserting in for vagina, rectum, or through incision in intestine. Treats diabetes mellitus, hyperlipemia (lipid metabolism), atherosclerosis, relieves stress and depression, chronic constipation, sexual disturbances, detoxification, ischemic heart disease, cardiac arrhythmia, paralysis, and enhances immunity level. 8/7/1996

74 - - - -- Cardiovascular
Date Published: 09/16/2009

Notes: Automatic Electronic Stimulator a.k.a: Autonomous Electronic Stimulator AES, Life Saver (a small capsule swallowing, inserting in for vagina, rectum, or through incision in intestine. Treats diabetes mellitus, hyperlipemia (lipid metabolism), atherosclerosis, relieves stress and depression, chronic constipation, sexual disturbances, detoxification, ischemic heart disease, cardiac arrhythmia, paralysis, and enhances immunity level. 8/7/1996

76 - - - -- Dental
Date Published: 09/16/2009

Notes: Automatic Electronic Stimulator a.k.a: Autonomous Electronic Stimulator AES, Life Saver (a small capsule swallowing, inserting in for vagina, rectum, or through incision in intestine. Treats diabetes mellitus, hyperlipemia (lipid metabolism), atherosclerosis, relieves stress and depression, chronic constipation, sexual disturbances, detoxification, ischemic heart disease, cardiac arrhythmia, paralysis, and enhances immunity level. 8/7/1996

77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009

Notes: Automatic Electronic Stimulator a.k.a: Autonomous Electronic Stimulator AES, Life Saver (a small capsule swallowing, inserting in for vagina, rectum, or through incision in intestine. Treats diabetes mellitus, hyperlipemia (lipid metabolism), atherosclerosis, relieves stress and depression, chronic constipation, sexual disturbances, detoxification, ischemic heart disease, cardiac arrhythmia, paralysis, and enhances immunity level. 8/7/1996

78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009

Notes: Automatic Electronic Stimulator a.k.a: Autonomous Electronic Stimulator AES, Life Saver (a small capsule swallowing, inserting in for vagina, rectum, or through incision in intestine. Treats diabetes mellitus, hyperlipemia (lipid metabolism), atherosclerosis, relieves stress and depression, chronic constipation, sexual disturbances, detoxification, ischemic heart disease, cardiac arrhythmia, paralysis, and enhances immunity level. 8/7/1996

79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009

Notes: Automatic Electronic Stimulator a.k.a: Autonomous Electronic Stimulator AES, Life Saver (a small capsule swallowing, inserting in for vagina, rectum, or through incision in intestine. Treats diabetes mellitus, hyperlipemia (lipid metabolism), atherosclerosis, relieves stress and depression, chronic constipation, sexual disturbances, detoxification, ischemic heart disease, cardiac arrhythmia, paralysis, and enhances immunity level. 8/7/1996

80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009

Notes: Automatic Electronic Stimulator a.k.a: Autonomous Electronic Stimulator AES, Life Saver (a small capsule swallowing, inserting in for vagina, rectum, or through incision in intestine. Treats diabetes mellitus, hyperlipemia (lipid metabolism), atherosclerosis, relieves stress and depression, chronic constipation, sexual disturbances, detoxification, ischemic heart disease, cardiac arrhythmia, paralysis, and enhances immunity level. 8/7/1996

84 - - - -- Neurological
Date Published: 09/16/2009

Notes: Automatic Electronic Stimulator a.k.a: Autonomous Electronic Stimulator AES, Life Saver (a small capsule swallowing, inserting in for vagina, rectum, or through incision in intestine. Treats diabetes mellitus, hyperlipemia (lipid metabolism), atherosclerosis, relieves stress and depression, chronic constipation, sexual disturbances, detoxification, ischemic heart disease, cardiac arrhythmia, paralysis, and enhances immunity level. 8/7/1996

85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009

Notes: Automatic Electronic Stimulator a.k.a: Autonomous Electronic Stimulator AES, Life Saver (a small capsule swallowing, inserting in for vagina, rectum, or through incision in intestine. Treats diabetes mellitus, hyperlipemia (lipid metabolism), atherosclerosis, relieves stress and depression, chronic constipation, sexual disturbances, detoxification, ischemic heart disease, cardiac arrhythmia, paralysis, and enhances immunity level. 8/7/1996

86 - - - -- Ophthalmic
Date Published: 09/16/2009

Notes: Automatic Electronic Stimulator a.k.a: Autonomous Electronic Stimulator AES, Life Saver (a small capsule swallowing, inserting in for vagina, rectum, or through incision in intestine. Treats diabetes mellitus, hyperlipemia (lipid metabolism), atherosclerosis, relieves stress and depression, chronic constipation, sexual disturbances, detoxification, ischemic heart disease, cardiac arrhythmia, paralysis, and enhances immunity level. 8/7/1996

87 - - - -- Orthopedic
Date Published: 09/16/2009

Notes: Automatic Electronic Stimulator a.k.a: Autonomous Electronic Stimulator AES, Life Saver (a small capsule swallowing, inserting in for vagina, rectum, or through incision in intestine. Treats diabetes mellitus, hyperlipemia (lipid metabolism), atherosclerosis, relieves stress and depression, chronic constipation, sexual disturbances, detoxification, ischemic heart disease, cardiac arrhythmia, paralysis, and enhances immunity level. 8/7/1996

89 - - - -- Physical Medicine
Date Published: 09/16/2009

Notes: Automatic Electronic Stimulator a.k.a: Autonomous Electronic Stimulator AES, Life Saver (a small capsule swallowing, inserting in for vagina, rectum, or through incision in intestine. Treats diabetes mellitus, hyperlipemia (lipid metabolism), atherosclerosis, relieves stress and depression, chronic constipation, sexual disturbances, detoxification, ischemic heart disease, cardiac arrhythmia, paralysis, and enhances immunity level. 8/7/1996

90 - - - -- Radiological
Date Published: 09/16/2009

Notes: Automatic Electronic Stimulator a.k.a: Autonomous Electronic Stimulator AES, Life Saver (a small capsule swallowing, inserting in for vagina, rectum, or through incision in intestine. Treats diabetes mellitus, hyperlipemia (lipid metabolism), atherosclerosis, relieves stress and depression, chronic constipation, sexual disturbances, detoxification, ischemic heart disease, cardiac arrhythmia, paralysis, and enhances immunity level. 8/7/1996


UKRAINE


Consultative & Commercial Center " INVET"
Date Published : 09/16/2009
Ac. Zabolotny Str 35/37 , Odessa, UKRAINE
89 I - - PF Stimulator, Muscle, Powered
Date Published: 01/07/2020

Desc: ENART TENS Devices
Notes: Product declared as "VIBROMASSAGER" and labeled as a "BIOFEEDBACK" device with indications for use that require 510(k) clearance. Product lacks registration, listing, and 510(k) clearance. Claims related to disorders of the Central Nervous System; the Peripheral Nervous System; the respiratory system; etc.; as well as dental diseases. Published 2/6/2008.


UNITED KINGDOM


Bruce Copen Laboratories
Date Published : 09/16/2009
Highfield Dane Hill , Sussex, UNITED KINGDOM
73 - - - -- Anesthesiology
Date Published: 09/16/2009

Notes: Radionic instruments intended for use in diagnosis of internal diseases (including models MK7, MK 12, ASLD95, MARS III) and assessories. 9/3/2002

74 - - - -- Cardiovascular
Date Published: 09/16/2009

Notes: Radionic instruments intended for use in diagnosis of internal diseases (including models MK7, MK 12, ASLD95, MARS III) and assessories. 9/3/2002

76 - - - -- Dental
Date Published: 09/16/2009

Notes: Radionic instruments intended for use in diagnosis of internal diseases (including models MK7, MK 12, ASLD95, MARS III) and assessories. 9/3/2002

77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009

Notes: Radionic instruments intended for use in diagnosis of internal diseases (including models MK7, MK 12, ASLD95, MARS III) and assessories. 9/3/2002

78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009

Notes: Radionic instruments intended for use in diagnosis of internal diseases (including models MK7, MK 12, ASLD95, MARS III) and assessories. 9/3/2002

79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009

Notes: Radionic instruments intended for use in diagnosis of internal diseases (including models MK7, MK 12, ASLD95, MARS III) and assessories. 9/3/2002

80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009

Notes: Radionic instruments intended for use in diagnosis of internal diseases (including models MK7, MK 12, ASLD95, MARS III) and assessories. 9/3/2002

84 - - - -- Neurological
Date Published: 09/16/2009

Notes: Radionic instruments intended for use in diagnosis of internal diseases (including models MK7, MK 12, ASLD95, MARS III) and assessories. 9/3/2002

85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009

Notes: Radionic instruments intended for use in diagnosis of internal diseases (including models MK7, MK 12, ASLD95, MARS III) and assessories. 9/3/2002

86 - - - -- Ophthalmic
Date Published: 09/16/2009

Notes: Radionic instruments intended for use in diagnosis of internal diseases (including models MK7, MK 12, ASLD95, MARS III) and assessories. 9/3/2002

87 - - - -- Orthopedic
Date Published: 09/16/2009

Notes: Radionic instruments intended for use in diagnosis of internal diseases (including models MK7, MK 12, ASLD95, MARS III) and assessories. 9/3/2002

89 - - - -- Physical Medicine
Date Published: 09/16/2009

Notes: Radionic instruments intended for use in diagnosis of internal diseases (including models MK7, MK 12, ASLD95, MARS III) and assessories. 9/3/2002

90 - - - -- Radiological
Date Published: 09/16/2009

Notes: Radionic instruments intended for use in diagnosis of internal diseases (including models MK7, MK 12, ASLD95, MARS III) and assessories. 9/3/2002

Savec Health Systems
Date Published : 09/16/2009
120 Deramore Avenue , Northern Ireland , Belfast, UNITED KINGDOM
73 C - - AW Generator, Oxygen, Portable
Date Published: 12/10/2019

Desc: Omnivir Device (oxygen generator)
Notes: The device is also misbranded under Section 502(a) 21 U.S.C. 352(a) in that the labeling for the Omnivir device contains statements which represent or suggest that the device is adequate and effective to, "Fight HIV/AIDS and related opportunistic infections and protecting the immune system," which representations or suggestions are false or misleading or otherwise contrary to fact because the device is not adequate or effective for such purposes. The Omnivir device is also misbranded under section 502(j) of the Act, 21 U.S.C. 352(j), in that the device is dangerous to health when used in the manner, or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof. 12/17/2008.

Sussex College of Technology
Date Published : 09/16/2009
Waltham Forest Business Center , 5 Blackhorse Lane , London, UNITED KINGDOM
73 - - - -- Anesthesiology
Date Published: 09/16/2009

Notes: Radionic instruments intended for use in diagnosis of internal diseases (including models MK7, MK 12, ASLD95, MARS III) and assessories. 9/3/2002

74 - - - -- Cardiovascular
Date Published: 09/16/2009

Notes: Radionic instruments intended for use in diagnosis of internal diseases (including models MK7, MK 12, ASLD95, MARS III) and assessories. 9/3/2002

76 - - - -- Dental
Date Published: 09/16/2009

Notes: Radionic instruments intended for use in diagnosis of internal diseases (including models MK7, MK 12, ASLD95, MARS III) and assessories. 9/3/2002

77 - - - -- Ear,Nose And Throat
Date Published: 09/16/2009

Notes: Radionic instruments intended for use in diagnosis of internal diseases (including models MK7, MK 12, ASLD95, MARS III) and assessories. 9/3/2002

78 - - - -- Gastroenterological & Urological
Date Published: 09/16/2009

Notes: Radionic instruments intended for use in diagnosis of internal diseases (including models MK7, MK 12, ASLD95, MARS III) and assessories. 9/3/2002

79 - - - -- General & Plastic Surgery
Date Published: 09/16/2009

Notes: Radionic instruments intended for use in diagnosis of internal diseases (including models MK7, MK 12, ASLD95, MARS III) and assessories. 9/3/2002

80 - - - -- General Hospital/Personal Use
Date Published: 09/16/2009

Notes: Radionic instruments intended for use in diagnosis of internal diseases (including models MK7, MK 12, ASLD95, MARS III) and assessories. 9/3/2002

84 - - - -- Neurological
Date Published: 09/16/2009

Notes: Radionic instruments intended for use in diagnosis of internal diseases (including models MK7, MK 12, ASLD95, MARS III) and assessories. 9/3/2002

85 - - - -- Obstetrical & Gynecological
Date Published: 09/16/2009

Notes: Radionic instruments intended for use in diagnosis of internal diseases (including models MK7, MK 12, ASLD95, MARS III) and assessories. 9/3/2002

86 - - - -- Ophthalmic
Date Published: 09/16/2009

Notes: Radionic instruments intended for use in diagnosis of internal diseases (including models MK7, MK 12, ASLD95, MARS III) and assessories. 9/3/2002

87 - - - -- Orthopedic
Date Published: 09/16/2009

Notes: Radionic instruments intended for use in diagnosis of internal diseases (including models MK7, MK 12, ASLD95, MARS III) and assessories. 9/3/2002

89 - - - -- Physical Medicine
Date Published: 09/16/2009

Notes: Radionic instruments intended for use in diagnosis of internal diseases (including models MK7, MK 12, ASLD95, MARS III) and assessories. 9/3/2002

90 - - - -- Radiological
Date Published: 09/16/2009

Notes: Radionic instruments intended for use in diagnosis of internal diseases (including models MK7, MK 12, ASLD95, MARS III) and assessories. 9/3/2002