Company ยท US
Bioness, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2011 to 2022. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 23, 2022 | K211965 | StimRouter Neuromodulation System Bioness, Inc. | GZF |
| Mar 27, 2020 | K200482 | StimRouter Neuromodulation System Bioness, Inc. | GZF |
| Mar 4, 2020 | K200262 | L100 Go System Bioness, Inc. | GZI |
| Oct 31, 2019 | K190047 | StimRouter Neuromodulation System Bioness, Inc. | GZF |
| Sep 12, 2019 | K191587 | L360 Thigh System Bioness, Inc. | GZI |
| Mar 14, 2019 | K190285 | L300 Go System Bioness, Inc. | GZI |
| Mar 9, 2018 | K173682 | L300 Go System Bioness, Inc. | GZI |
| Jan 27, 2017 | K162407 | L300 Go System Bioness, Inc. | GZI |
| Feb 20, 2015 | K142432 | StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit Bioness, Inc. | GZF |
| May 1, 2013 | K123636 | H200 WIRELESS HAND REHABILITATION SYSTEM WITH OPTIONAL INTELLI-CONNECT EARPIECE TRIGGERING DEVICE Bioness, Inc. | GZI |
| Dec 27, 2012 | K122784 | NESS L300 SYSTEM KIT, LEF MODEL LG3-5100; NESS L300 SYSTEM KIT, RIGHT MODEL LG3-5000; SMALL NESS L300 SYSTEM KIT, RIGHT Bioness, Inc. | GZI |
| Apr 20, 2012 | K120853 | NESS L300 SYSTEM KIT, LEFT, NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, Bioness, Inc. | GZI |
| Apr 29, 2011 | K103343 | L300 PLUS SYSTEM (RIGHT, LEFT), L300 PLUS SYSTEM UPGRADE KIT (RIGHT, LEFT) Bioness, Inc. | GZI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||