The following data is part of a premarket notification filed by Body Clock Health Care Ltd with the FDA for 804siii; 804w; Libra Tens; 410; S-tens Ii.
| Device ID | K021846 |
| 510k Number | K021846 |
| Device Name: | 804SIII; 804W; LIBRA TENS; 410; S-TENS II |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | BODY CLOCK HEALTH CARE LTD 108 GEORGE LANE London, England, GB E18 1ad |
| Contact | Jonathan Bash |
| Correspondent | Jonathan Bash BODY CLOCK HEALTH CARE LTD 108 GEORGE LANE London, England, GB E18 1ad |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-05 |
| Decision Date | 2002-11-22 |
| Summary: | summary |