The following data is part of a premarket notification filed by Bioness Inc. with the FDA for L360 Thigh System.
| Device ID | K191587 |
| 510k Number | K191587 |
| Device Name: | L360 Thigh System |
| Classification | Stimulator, Neuromuscular, External Functional |
| Applicant | Bioness Inc. 25103 Rye Canyon Loop Valencia, CA 91355 |
| Contact | Mercedes Bayani |
| Correspondent | Shanna Hu Bioness Inc. 25103 Rye Canyon Loop Valencia, CA 91355 |
| Product Code | GZI |
| CFR Regulation Number | 882.5810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-14 |
| Decision Date | 2019-09-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815962020399 | K191587 | 000 |
| 00815962020382 | K191587 | 000 |