Reference Source

Abby TENS · 89-08 · UNITED KINGDOM

For Abby TENS · 89-08 · UNITED KINGDOM, 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 KINGDOM; 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 2026-09-16.

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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Abby TENS Date Published : 09/16/2009 46 Cambridge Street , Wolverton , Milton Keynes, UNITED KINGDOM 84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief Date Published: 09/16/2009 Notes: Obstetric TENS Unit (Abby TENS) 5/15/2003.

accessdata.fda.gov, retrieved 2026-09-15

Source

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