IA #78-01 - 5/18/93 REVISED, "Penis Enlargers and Erection Maintaining Rings" Attachment A 7/27/04 TYPE OF ALERT: Automatic Detention PRODUCT : Penis Enlargers Erection Maintaining Devices PRODUCT CODE : 78----- HARMONIZED CODE : 9021 PROBLEM : Inadequate directions for use (DRDW) PAC FOR COLLECTION : 82008 COUNTRY : All MANUFACTURER OR SHIPPER : All MANUFACTURER OR SHIPPER I.D.#: N/A IMPORTER'S I.D. # : N/A 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)]." RECOMMENDING OFFICE : Division of Import Operations & Policy, HFC-170 and CDRH, HFZ-323 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 Known manufacturers whose products have been detained in FY 90-92 include: Manufacturer Country Device Namma Manufacturing Hong Kong Erection Maintaining Device Furuta Shokai Japan Erection Maintaining Device Hanook Latex Korea Constrictive Ring Universal Products Japan Vibro Power Erection Device INSTRUCTIONS : Unless exempted by Section 801.109, automatically detain all devices in the above described categories. If there is any question whether or not any device encountered falls into the above described categories, contact Division of Compliance Operations, HFZ-323, at 301-427-1116. PRIORITIZATION GUIDANCE : N/A FOI : No purging is required KEYWORDS : Erection Maintaining Devices, Penis Enlargers, Constrictive Rings, Supportive Devices PREPARED BY : Linda Wisniowski, DIOP, 301-443-6553. TAIWAN (TW) Firm(s) Product(s)/Code(s) Win Actity Company Vicon Vibrating Ring & Condom/78 3F, No. 565, Sec. 4 (85H -IS) Jhongsiao E. Road 7/27/04 Sinyl District Taipei City 110 Taiwan FEI #3004527699