Abby TENS · 89-08 · UNITED KINGDOM
For Abby TENS, import alert is 89-08; country is UNITED KINGDOM; 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 code is 84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief; date published is 09/16/2009; address is 46 Cambridge Street , Wolverton , Milton Keynes, UNITED KINGDOM, verified against its source on 2026-09-30.
- Firm
- Abby TENS 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 KINGDOM verified
- Address
- 46 Cambridge Street , Wolverton , Milton Keynes, UNITED KINGDOM verified
- Date published
- 09/16/2009 verified
- Product code
- 84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief verified
- FDA notes
- Obstetric TENS Unit (Abby TENS) 5/15/2003. verified
What the source says
Abby TENS Date Published : 09/16/2009 46 Cambridge Street , Wolverton , Milton Keynes, UNITED KINGDOM
— 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 and FDA notes
84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief Date Published: 09/16/2009 Notes: Obstetric TENS Unit (Abby TENS) 5/15/2003.
— all from 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.