The following data is part of a premarket notification filed by Vupiesse S.r.l with the FDA for Tua Face Fitness / Tua Trend Face.
| Device ID | K192077 |
| 510k Number | K192077 |
| Device Name: | Tua Face Fitness / Tua Trend Face |
| Classification | Stimulator, Transcutaneous Electrical, Aesthetic Purposes |
| Applicant | Vupiesse S.R.L Via Della Lontra, 49 Rimini Rn, IT 47923 |
| Contact | Marco Paolizzi |
| Correspondent | Chuck H. Mograbi Silicus Technologies 2700 Post Oak Blvd #1625 Houston, TX 77056 |
| Product Code | NFO |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-02 |
| Decision Date | 2020-09-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08017129000912 | K192077 | 000 |