Data / Medical devices / United Kingdom / Body Clock Health Care Ltd
Body Clock Health Care Ltd: FDA-registered device maker in LONDON, ENGLAND London, City of, United Kingdom, 9 510(k) clearances
Body Clock Health Care Ltd is registered with the FDA (registration 9710616) in LONDON, ENGLAND London, City of, United Kingdom. It lists 2 device types. The FDA files 9 510(k) clearances under its listings, the newest dated December 18, 2009. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 9710616
- FEI number
- 3003267895
- Address
- 108 George Lane, LONDON, ENGLAND London, City of, United Kingdom, E18 1AD
- Owner or operator
- BODY CLOCK HEALTH CARE LTD (9048152)
- Roles
- Exporter to the US, Manufacturer, Repackager or relabeler
- First device listed
- April 8, 2008
- Registered through
- 2026
- Brand names listed
- 1st Choice EMS, Body Clock Duo, Body Clock Stimplus, Body Clock Stimplus Pro, First Choice, First Choice Plus, Flexi TENS, Libra TENS and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Stimulator, Muscle, Powered | IPF | 2 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | 2 | Exporter to the US, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 18, 2009 | K091045 | SMART TENS, MODEL: D-BC05T | GZJ | Substantially Equivalent | Body Clock Health Care, Ltd. | accessdata.fda.gov |
| January 25, 2006 | K052813 | FD TENS 2030, MODEL DFJ24T | GZJ | Substantially Equivalent | Fuji Dynamics Limited | accessdata.fda.gov |
| August 20, 2004 | K041359 | BODY CLOCK STIMPLUS AND STIMPLUS PRO | GZJ | Substantially Equivalent | Body Clock Health Care, Ltd. | accessdata.fda.gov |
| May 20, 2004 | K041164 | L-TENS | GZJ | Substantially Equivalent | Fuji Dynamics Limited | accessdata.fda.gov |
| May 20, 2003 | K022849 | BODY CLOCK TENS N' TONE | GZJ | Substantially Equivalent | Body Clock Health Care, Ltd. | accessdata.fda.gov |
| November 22, 2002 | K021846 | 804SIII; 804W; LIBRA TENS; 410; S-TENS II | GZJ | Substantially Equivalent | Body Clock Health Care, Ltd. | accessdata.fda.gov |
| November 14, 2002 | K022731 | V TENS PLUS | GZJ | Substantially Equivalent | Body Clock Health Care, Ltd. | accessdata.fda.gov |
| October 11, 2002 | K022493 | EMS 400 | IPF | Substantially Equivalent | Body Clock Health Care, Ltd. | accessdata.fda.gov |
| September 24, 2002 | K022076 | FIRST CHOICE & FIRST CHOICE PLUS | GZJ | Substantially Equivalent | Body Clock Health Care, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Nerve, Transcutaneous, For Pain Relief
- All makers of Stimulator, Muscle, Powered
Updated December 18, 2009. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.