The following data is part of a premarket notification filed by Tenscare Ltd. with the FDA for Perfect Ems.
| Device ID | K200694 |
| 510k Number | K200694 |
| Device Name: | Perfect EMS |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | TensCare Ltd. 9 Blenheim Road, Longmead Business Park Epsom, GB Kt19 9be |
| Contact | Andrew Brown |
| Correspondent | Andrew Brown TensCare Ltd. 9 Blenheim Road, Longmead Business Park, Epsom, GB Kt19 9be |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-17 |
| Decision Date | 2021-06-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05033435136483 | K200694 | 000 |
| 05033435136759 | K200694 | 000 |
| 05033435131419 | K200694 | 000 |
| 05033435120239 | K200694 | 000 |
| 05033435136209 | K200694 | 000 |