The following data is part of a premarket notification filed by Bios S.r.l. with the FDA for Nuera Tight Family, Ems Model.
| Device ID | K201239 |
| 510k Number | K201239 |
| Device Name: | NuEra Tight Family, EMS Model |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | Bios S.r.l. Via Guido Rossa 10/12 Vimodrone, IT 20090 |
| Contact | Maurizio Bianchi |
| Correspondent | Maurizio Bianchi Bios S.r.l. Via Guido Rossa 10/12 Vimodrone, IT 20090 |
| Product Code | NGX |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-07 |
| Decision Date | 2020-12-31 |