UROMATRIX Medical Systems (A Pos-T-Vac Medical Company) · 89-08 · UNITED STATES
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
- 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
- Address
- 4811 Technology Dr , Martinez, GA 30907-2606 UNITED STATES verified
- Date published
- 04/20/2011 verified
- Product code
- 78 L - - KY Device, External Penile Rigidity verified
- Product
- Medical Extender Andro Penis Extender verified
- FDA notes
- Class II Lacks 510(K) verified
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)
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.