Import Alert 78-01

(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 # 78-01
Published Date: 05/19/2023
Type: DWPE

Import Alert Name:

"Detention Without Physical Examination Of External Penile Rigidity Devices"

Reason for Alert:

Note: The revision of this Import Alert (IA) dated 5/19/2023 updates the reason for alert and guidance section, product description section,
and charge code language. Changes to the import alert are bracketed by asterisks (***).

The use of external penile rigidity devices may have harmful effects such as, aggravating existing medical conditions such as Peyronie's
disease, priapism, and urethral stricture. They may injure or cause rupture of the subcutaneous blood vessels, which may produce
hemorrhage and hematoma formation. Additionally, frequent use of erection maintaining rings may result in ***discoloration of the
skin, typically caused by bruising*** of the proximal portion of the penis and scrotum, and the lymphatic stasis of the penis. Prolonged
use of the rings may cause gangrene of the penis.

These devices generally fall into the following categories and these products should follow the Class II Special Controls Guidance Document, External Penile Rigidity Device Guidance for Industry and FDA Staff:

1. Vacuum pumps

Those employing a sealing principle in the area of the base of the penis and an evacuation mechanism to drop the atmospheric pressure around the penis thereby effecting increased blood flow.

2. Constriction Rings

Those devices which constrict the base of the penis after erection has been achieved and cause the erection to be maintained by blocking the
normal circulation of blood from the penis.

3. Penile splints

Those devices are flexible support structures intended to be attached to or placed along the penis to hold the penis erect during sexual intercourse. Penile splints include a quick release mechanism to
enable quick removal.

***The Red List of this Alert contains products where*** labeling falsely states or imply they will treat or improve the performance
of the following conditions or products:

Mechanical penile extenders
Foreskin remodeling or restoration
Penile enhancement, such as penis enlargement
Treatment of diseases or conditions of the penis with respect to
curvature and other penis deformities, e.g., Peyronie's Disease
Prevention or reversal of erectile dysfunction/impotence
Retaining a condom on the penis

Guidance:

Divisions may detain, without physical examination, ***shipments of the indicated products from the firms identified on the Red List for this
import alert.***

A recommendation for addition to detention without physical examination should be forwarded to the Division of Import Operations (DIO). DIO will coordinate a review of all recommendations for addition to detention
without physical examination with CDRH, Imports and Registration and
Listing Team.

Divisions may also be able to recommend a detention without physical examination of such devices under IA 89-08, "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices
Not Substantially Equivalent or Without a 510(k)."

Release of Articles Subject to Detention Without Physical Examination Under This Import Alert:

***In order to secure release of an individual shipment identified for DWPE under this import alert, the owner, consignee, and/or other responsible party of the affected goods should provide*** a written application (Form FDA 766) requesting authorization to bring a device that has been detained without physical examination per this import alert into compliance by relabeling or other action (reconditioning),
or by rendering it other than a device. ***All documentation should be submitted to the appropriate FDA Division compliance office for consideration per the "FDA Notice of Detention and Hearing." Divisions
will refer such applications related to this alert to CDRH, Imports and Registration and Listing Team for concurrence. For more information about reconditioning, refer to the FDA Regulatory Procedures Manual
(RPM), Chapter 9, "9-12 Reconditioning," which is located on FDA's website. ***

Requests for removal from detention without physical examination (REMOVE FROM RED LIST):

In order to remove a firm's product from detention without physical examination, ***information should be provided to the Agency to adequately demonstrates 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 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 FDA at the following address:

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

Or via email: Importalerts2@fda.hhs.gov

Questions or issues involving import operations, contact the Division of Import Operations at 301-796-0356 or fdaimportsinquiry@fda.hhs.gov

Questions or issues on policy concerning these types of products or other compliance issues should be addressed to CDRH Imports and Registration
and Listing Team at cdrhimport@fda.hhs.gov

                                                                                                                                                                       

Product Description:

***Vacuum pumps, Constriction rings, and penile splints***

Charge:

***"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a device
whose label appears to not bear adequate directions for use."*** [Misbranding, Section 502(f)(1)]

OASIS CHARGE CODE: DIRECTIONS

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


CHINA


GIZMOSPRING.COM DONGGUAN LIMITED
Date Published : 01/12/2015
Banshi Village , Unit Q3/F Nanpu Innovation And Technology Center; Changping Town , Dongguan City, Guangdong CHINA
78 L - - KY Device, External Penile Rigidity
Date Published: 04/24/2019

Desc: Clit Ring
Notes: Class II

78 L - - KY Device, External Penile Rigidity
Date Published: 04/24/2019

Desc: Cock Ring Set
Notes: Class II

78 L - - KY Device, External Penile Rigidity
Date Published: 04/24/2019

Desc: Squeeze Cock
Notes: Class II

78 L - - KY Device, External Penile Rigidity
Date Published: 04/24/2019

Desc: Cock Ring
Notes: Class II

78 L - - KY Device, External Penile Rigidity
Date Published: 04/24/2019

Desc: Power Ring
Notes: Class II

78 L - - KY Device, External Penile Rigidity
Date Published: 04/24/2019

Desc: Bead Ring Set
Notes: Class II

78 L - - KY Device, External Penile Rigidity
Date Published: 04/24/2019

Desc: Cock Grip
Notes: Class II

78 L - - KY Device, External Penile Rigidity
Date Published: 04/24/2019

Desc: Swell Cock Ring
Notes: Class II

78 L - - KY Device, External Penile Rigidity
Date Published: 04/24/2019

Desc: Metal Ring Starter
Notes: Class II

78 L - - KY Device, External Penile Rigidity
Date Published: 04/24/2019

Desc: 8 Ring
Notes: Class II

78 L - - KY Device, External Penile Rigidity
Date Published: 04/24/2019

Desc: External penile rigidity devices; Vibro Rabbit Ring
Notes: Class II

Hongkong Canwin Li Health Products
Date Published : 04/20/2016
2nd Floor , Chuangyujindidatechnology , Shenzhen, CHINA
78 L - - KY Device, External Penile Rigidity
Date Published: 04/20/2016

Desc: PowerUp Penis Pump

Lovetoys Industrial Co Ltd
Date Published : 04/07/2015
Chao Hsuan Tech Park , B Block Hung Tu Rd; Nancheng , Dongguan, Guangdong CHINA
78 L - - KY Device, External Penile Rigidity
Date Published: 04/07/2015

Desc: Penis Enlargement Pump

78 L - - KY Device, External Penile Rigidity
Date Published: 04/07/2015

Desc: Master Gauge Penis Pump

78 L - - KY Device, External Penile Rigidity
Date Published: 04/07/2015

Desc: Proextender Penis Enlargement System

78 L - - KY Device, External Penile Rigidity
Date Published: 04/07/2015

Notes: Various Constricting Rings; Silicone Prolong Ring; Peter North's Get Hard Cock Rings; Rainbow Silicone Pleasure Rings; Love Ring Trio; Sex Love-Time Vibrator Ring; Power Bud Clit Cock Ring; Power Love Clit Cockring.

89 I - - SA Massager, Therapeutic, Electric
Date Published: 04/07/2015

Desc: Proextender Penis Enlargement System

89 I - - SA Massager, Therapeutic, Electric
Date Published: 04/07/2015

Desc: Master Gauge Penis Pump

89 I - - SA Massager, Therapeutic, Electric
Date Published: 04/07/2015

Desc: Penis Enlargement Pump

89 I - - SA Massager, Therapeutic, Electric
Date Published: 04/07/2015

Notes: Various Constricting Rings; Silicone Prolong Ring; Peter North's Get Hard Cock Rings; Rainbow Silicone Pleasure Rings; Love Ring Trio; Sex Love-Time Vibrator Ring; Power Bud Clit Cock Ring; Power Love Clit Cockring.

89 L - - YG Massager, Therapeutic, Manual
Date Published: 04/07/2015

Desc: Penis Enlargement Pump

89 L - - YG Massager, Therapeutic, Manual
Date Published: 04/07/2015

Desc: Master Gauge Penis Pump

89 L - - YG Massager, Therapeutic, Manual
Date Published: 04/07/2015

Desc: Proextender Penis Enlargement System

89 L - - YG Massager, Therapeutic, Manual
Date Published: 04/07/2015

Notes: Various Constricting Rings; Silicone Prolong Ring; Peter North's Get Hard Cock Rings; Rainbow Silicone Pleasure Rings; Love Ring Trio; Sex Love-Time Vibrator Ring; Power Bud Clit Cock Ring; Power Love Clit Cockring.

Shenzhen Hong Ji Pu Technology Co., Ltd.
Date Published : 06/24/2016
Technology Park 3rd Floor , Gongming Town; Lisonglang 2nd Ind. Zone , Shenzhen, Guangdong CHINA
78 L - - KY Device, External Penile Rigidity
Date Published: 06/24/2016

Desc: Stay Hard Beaded Cockrings


UNITED KINGDOM


UM Products Ltd
Date Published : 04/06/2015
Unit 9a Horrace Waller VC Parade , Shaw Cross Business Park , Dewsbury, UNITED KINGDOM
78 L - - KY Device, External Penile Rigidity
Date Published: 04/06/2015

Desc: Hercules Penis Pump

78 L - - KY Device, External Penile Rigidity
Date Published: 04/06/2015

Desc: Hydromax Penis Pump

89 I - - SA Massager, Therapeutic, Electric
Date Published: 04/06/2015

Desc: Hercules Penis Pump

89 I - - SA Massager, Therapeutic, Electric
Date Published: 04/06/2015

Desc: Hydromax Penis Pump