UROMATRIX Medical Systems (A Pos-T-Vac Medical Company) · 89-08 · UNITED STATES
For UROMATRIX Medical Systems (A Pos-T-Vac Medical Company), import alert is 89-08; country is UNITED STATES; 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)"; 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 2026-09-30.
- 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
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
78 L - - KY Device, External Penile Rigidity Date Published: 04/20/2011 Desc: Medical Extender Andro Penis Extender Notes: Class II Lacks 510(K)
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html