510(k) K260319 · IOR Wheelchair, Mechanical
K5 wheelchair (16 with swing-away footrest 18 with swing-away footrest 20 with swing-away footrest 16 with elevated foot rest(ELR) 18 with elevated foot rest(ELR) 20 with elevated foot rest(ELR))
| Applicant | Zhenjiang Assure Medical Equipment Co., Ltd., Zhenjiang, CN |
| Decision | Substantially Equivalent, Mar 31, 2026 |
| Received | Jan 30, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260319
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.