CROSS SPORT, RIGID WHEELCHAIR— 510(k) K990358
Substantially EquivalentTisport
FDA 510(k) clearance K990358 for CROSS SPORT, RIGID WHEELCHAIR, Substantially Equivalent on 1999-02-26. Applicant: Tisport. Device class: 1.
Clearance details
- Applicant
- Tisport
- Product code
- Code IOR
- Device class
- Class 1
- Regulation
- 21 CFR 890.3850
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kennewick, WA, US
Recent devices under product code IOR
view allMore clearances from Tisport
view allAdverse events under product code IOR
product code IOR- Death
- 10
- Injury
- 232
- Other
- 2
- Total
- 244
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K990358
K-number listed on FDA's recall record- Z-0264-2022 — Permobil TiLite, Models: Aero Z, and ZRA
- Z-2294-2019 — 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 affected component is part of a manual wheelchair to provide mobility to physically impaired individuals. The affected component is used to prevent the wheelchair from tipping backwards.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K990358.
Data sourced from openFDA. This site is unofficial and independent of the FDA.