The following data is part of a premarket notification filed by Body Clock Health Care Ltd with the FDA for Body Clock Stimplus And Stimplus Pro.
| Device ID | K041359 |
| 510k Number | K041359 |
| Device Name: | BODY CLOCK STIMPLUS AND STIMPLUS PRO |
| 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 | 2004-05-21 |
| Decision Date | 2004-08-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060079210262 | K041359 | 000 |