510(k) K170507 · ITI Wheelchair, Powered
Invacare® TDX® SP2 Power Wheelchair; TDXSP2 TDX SP2 with LiNX Electronics, TDXSP2-CG TDX SP2 Base for Single Act. System w/ Ultra Low Maxx, TDXSP2-MCG TDX SP2 Base for Multiple Actuator System w/ Ultra Low Maxx
| Applicant | Invacare Corporation, Elyria OH, US |
| Decision | Substantially Equivalent, Jul 12, 2017 |
| Received | Feb 21, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170507
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 30, 2022 | Invacare Corporation Invacare TDX SP2, Model Nos. TDXSP2
TDXSP2-MCG
TDXSP2V Open, Classified |
ITI | None listed |
| Nov 12, 2021 | Invacare Corporation Invacare TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A)
Models: TDX SP2: TDXSP2, TDXSP2-CG, TDXSP2X-CG, TDXSP2-MCG, TDXSP2X-MCG, TDXSP2V, T Open, Classified |
ITI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.