510(k) K052329 ยท GZI Stimulator, Neuromuscular, External Functional
WALKAIDE SYSTEM, MODELS 20-0100, 20-0310, 20-1000
| Applicant | Innovative Neurotronics, Inc., Bethesda MD, US |
| Decision | Substantially Equivalent, Sep 21, 2005 |
| Received | Aug 25, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K052329
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 3, 2009 | Innovative Neurotronics, Inc. WalkAide Stimulator System Control Module, Part Number 20-0100; component of the WalkAide Stimulator System; distributed by Innovative Neurotronics, Austin, TX 78746.
The WalkAide is a battery opera Terminated |
GZI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.