Body Clock Health Care Ltd · 89-08 · UNITED KINGDOM
For Body Clock Health Care Ltd, 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 is ElleTENS and ElleTENS 2 | ElleTENS and ElleTENS 2; product code is 84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief | 89 I - - SA Massager, Therapeutic, Electric; date published is 03/05/2026; address is 108 George Lane , SOUTH WOODFORD , London, UNITED KINGDOM, verified against its source on 2026-09-30.
- Firm
- Body Clock Health Care Ltd 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
- 108 George Lane , SOUTH WOODFORD , London, UNITED KINGDOM verified
- Date published
- 03/05/2026 verified
- Product code
- 84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief | 89 I - - SA Massager, Therapeutic, Electric each item verified
- Product
- ElleTENS and ElleTENS 2 | ElleTENS and ElleTENS 2 each item verified
What the source says
Body Clock Health Care Ltd Date Published : 03/05/2026 108 George Lane , SOUTH WOODFORD , London, 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 Product
84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief Date Published: 08/24/2026 Desc: ElleTENS and ElleTENS 2 89 I - - SA Massager, Therapeutic, Electric Date Published: 08/24/2026 Desc: ElleTENS and ElleTENS 2
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html