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: 04/25/2019
Type: DWPE

Import Alert Name:

"Detention Without Physical Examination Of Penis Enlargers And Erection Maintaining Rings"

Reason for Alert:

The use of penis enlargers and erection maintaining rings may have harmful effects. They may aggravate existing medical conditions such a Pegronies disease, priapism, and urethral stricture. They may contuse 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 ecchymosis 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.



Basically, the labeling of these devices falsely states or implies they will treat impotence, prolong erection, and increase the dimensions of the penis.



These devices generally fall into the following categories:





1. Mechanical stretching devices.



Those employing weights, or lines tied to other parts of the body (such as the knee), to affect tension on the penis.



2. Vacuum operated devices.



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.



3. Constrictive 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.



4. Supportive devices.



Those devices which function as a splint or cradle in order to maintain a resemblance of turgidity

Guidance:

Districts may detain without physical examination, unless exempted by 21 CFR, Section 801.109, all devices in the above described categories.



Districts may also be able to detain such devices under IA 89-08, "DWPE of devices w/o approved PMA's or IDE's and other devices not equivalent or no 510K."



If there is any question whether or not any device encountered falls into the above described categories, contact CDRH, Division of Compliance Operations, HFZ-332.

Product Description:

Penis Enlargers

Erection Maintaining Devices

Charge:

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a device, the label of which fails to 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 Ltd
Date Published : 01/12/2015
3rd Floor, Qunhe Mold Factory , ZhutangVillage,Fenggang Town , Dongguan, 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