The following data is part of a premarket notification filed by Body Clock Health Care Ltd with the FDA for Smart Tens, Model: D-bc05t.
| Device ID | K091045 |
| 510k Number | K091045 |
| Device Name: | SMART TENS, MODEL: D-BC05T |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | BODY CLOCK HEALTH CARE LTD 108 GEORGE LANE South Woodford, London, GB E18 1ad |
| Contact | Rashelle Preston |
| Correspondent | Rashelle Preston BODY CLOCK HEALTH CARE LTD 108 GEORGE LANE South Woodford, London, 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 | 2009-04-13 |
| Decision Date | 2009-12-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060079210224 | K091045 | 000 |