510(k) K990358 ยท IOR Wheelchair, Mechanical
CROSS SPORT, RIGID WHEELCHAIR
| Applicant | Tisport, Kennewick WA, US |
| Decision | Substantially Equivalent, Feb 26, 1999 |
| Received | Feb 5, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K990358
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 24, 2021 | TiSport, Llc Permobil TiLite, Models: Aero Z, and ZRA Open, Classified |
IOR | None listed |
| Sep 11, 2018 | TiSport, Llc TiLite X-Short anti-tip tubes, models TRA, AERO T, ZRA, AERO Z, 2GX, AERO X, Twist, and AERO R, a component of the TiLite wheelchair (anti-tip extension for manual wheelchairs).
Product Usage:
The Terminated |
IOR | None listed |
| Sep 7, 2011 | TiSport, Llc TiLite ZR and ZRA Series 2 are mechanical wheelchairs. Devices are sold under brand name TiLite.
The TiLite ZR had a model catalog number of Z2FS1.
The TiLite ZRA has a model catalog number of Z2F Terminated |
IOR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.