The following data is part of a premarket notification filed by Bioness, Inc. with the FDA for Ness L300 System Kit, Left, Ness L300 System Kit, Right, Small Ness L300 System Kit, Right, Small Ness L300 System Kit,.
| Device ID | K120853 |
| 510k Number | K120853 |
| Device Name: | NESS L300 SYSTEM KIT, LEFT, NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, |
| Classification | Stimulator, Neuromuscular, External Functional |
| Applicant | BIONESS, INC. 25103 RYE CANYON LOOP Valencia, CA 91355 |
| Contact | Kim Tompkins |
| Correspondent | Kim Tompkins BIONESS, INC. 25103 RYE CANYON LOOP Valencia, CA 91355 |
| Product Code | GZI |
| CFR Regulation Number | 882.5810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-21 |
| Decision Date | 2012-04-20 |