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