# Body Clock Health Care Ltd · 89-08 · UNITED KINGDOM — FDA import alert red lists: firms subject to detention without physical examination

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: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** 108 George Lane , SOUTH WOODFORD , London, UNITED KINGDOM _(verified: appears in the quote below)_
- **Date published:** 03/05/2026 _(verified: appears in the quote below)_
- **Product code:** 84 G - - ZJ Stimulator, Nerve, Transcutaneous, For Pain Relief | 89 I - - SA Massager, Therapeutic, Electric _(verified: each item appears in the quote below)_
- **Product:** ElleTENS and ElleTENS 2 | ElleTENS and ElleTENS 2 _(verified: each item appears in the quote below)_

## 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

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).