The following data is part of a premarket notification filed by Heat In A Click Llc. with the FDA for Fitrelief Tens&ems Wireless Device.
| Device ID | K191938 |
| 510k Number | K191938 |
| Device Name: | FitRelief TENS&EMS Wireless Device |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | Heat In A Click LLC. 1975 Tigertail Blvd Dania, FL 33004 |
| Contact | Guy Levi |
| Correspondent | Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District Guangzhou, CN 510006 |
| Product Code | NGX |
| Subsequent Product Code | NFO |
| Subsequent Product Code | NUH |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-19 |
| Decision Date | 2020-08-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850018806800 | K191938 | 000 |
| 00850018806541 | K191938 | 000 |