510(k) K123636 ยท GZI Stimulator, Neuromuscular, External Functional
H200 WIRELESS HAND REHABILITATION SYSTEM WITH OPTIONAL INTELLI-CONNECT EARPIECE TRIGGERING DEVICE
| Applicant | Bioness, Inc., Valencia CA, US |
| Decision | Substantially Equivalent, May 1, 2013 |
| Received | Nov 23, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123636
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.