510(k) K200032 ยท PHL Powered Exoskeleton
ReWalk P6.0
| Applicant | Re Walk Robotics , Ltd., Yokneam, IL |
| Decision | Substantially Equivalent, May 26, 2020 |
| Received | Jan 7, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200032
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 28, 2020 | Argo Medical Technologies Ltd ReWalk Personal 6.0, ReWalk Personal 5.0 and ReWalk R Systems orthotically fits to the lower limbs and part of the upper body and is intended to enable individuals with spinal cord injury at levels T7 Terminated |
PHL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.