# UROMATRIX Medical Systems (A Pos-T-Vac Medical Company) · 89-08 · UNITED STATES — FDA import alert red lists: firms subject to detention without physical examination

For UROMATRIX Medical Systems (A Pos-T-Vac Medical Company) · 89-08 · UNITED STATES, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is UNITED STATES; product is Medical Extender Andro Penis Extender; product code is 78 L - - KY Device, External Penile Rigidity; date published is 04/20/2011; address is 4811 Technology Dr , Martinez, GA 30907-2606 UNITED STATES, verified against its source on 2026-09-16.

- **Firm:** UROMATRIX Medical Systems (A Pos-T-Vac Medical Company) _(verified: appears in the quote below)_
- **Import alert:** 89-08
- **Import alert name:** "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- **Country:** UNITED STATES _(verified: appears in the quote below)_
- **Address:** 4811 Technology Dr , Martinez, GA 30907-2606 UNITED STATES _(verified: appears in the quote below)_
- **Date published:** 04/20/2011 _(verified: appears in the quote below)_
- **Product code:** 78 L - - KY Device, External Penile Rigidity _(verified: appears in the quote below)_
- **Product:** Medical Extender Andro Penis Extender _(verified: appears in the quote below)_
- **FDA notes:** Class II Lacks 510(K) _(verified: appears in the quote below)_

## What the source says

> UROMATRIX Medical Systems (A Pos-T-Vac Medical Company) Date Published : 04/20/2011 4811 Technology Dr , Martinez, GA 30907-2606 UNITED STATES 78 L - - KY Device, External Penile Rigidity Date Published: 04/20/2011 Desc: Medical Extender Andro Penis Extender Notes: Class II Lacks 510(K)

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).