FDA 510(k) Applications Submitted by Bioness, Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K120853 |
03/21/2012 |
NESS L300 SYSTEM KIT, LEFT, NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, |
BIONESS, INC. |
| K122784 |
09/11/2012 |
NESS L300 SYSTEM KIT, LEF MODEL LG3-5100; NESS L300 SYSTEM KIT, RIGHT MODEL LG3-5000; SMALL NESS L300 SYSTEM KIT, RIGHT |
BIONESS, INC. |
| K123636 |
11/23/2012 |
H200 WIRELESS HAND REHABILITATION SYSTEM WITH OPTIONAL INTELLI-CONNECT EARPIECE TRIGGERING DEVICE |
BIONESS, INC. |
| K173682 |
12/01/2017 |
L300 Go System |
Bioness, Inc. |
| K142432 |
08/29/2014 |
StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/StimRouter User Kit |
BIONESS, INC. |
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