Body Clock Health Care Ltd · 89-08 · UNITED KINGDOM
For Body Clock Health Care Ltd · 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 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 2026-09-16.
- 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 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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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