510(k) K160987 ยท PHL Powered Exoskeleton
ReWalk(TM)
| Applicant | Rewalk Robotics, Inc., Marlborough MA, US |
| Decision | Substantially Equivalent, Jul 22, 2016 |
| Received | Apr 8, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K160987
| 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 |
| Aug 14, 2017 | Argo Medical Technologies Ltd ReWalk Personal 6.0. Catalog number: 50-20-0004. Terminated |
PHL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.