510(k) K192216 ยท ITI Wheelchair, Powered
Invacare AVIVA FX Power Wheelchair, Model: IFX-20MP
| Applicant | Invacare Corporation, Elyria OH, US |
| Decision | Substantially Equivalent, Jan 2, 2020 |
| Received | Aug 15, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192216
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 12, 2021 | Invacare Corporation Invacare AVIVA FX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A)
Models: IFX-20R, IFX-20SP, IFX-20MP, IFX-20C Open, Classified |
ITI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.