The following data is part of a premarket notification filed by Bioness, Inc. with the FDA for Ness L300 System Kit, Lef Model Lg3-5100; Ness L300 System Kit, Right Model Lg3-5000; Small Ness L300 System Kit, Right.
| Device ID | K122784 |
| 510k Number | K122784 |
| Device Name: | NESS L300 SYSTEM KIT, LEF MODEL LG3-5100; NESS L300 SYSTEM KIT, RIGHT MODEL LG3-5000; SMALL NESS L300 SYSTEM KIT, RIGHT |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-11 |
| Decision Date | 2012-12-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290110483098 | K122784 | 000 |
| 07290110483081 | K122784 | 000 |
| 07290110483074 | K122784 | 000 |
| 07290110483067 | K122784 | 000 |
| 07290110483050 | K122784 | 000 |