CROSS SPORT, RIGID WHEELCHAIR
FDA 510(k) clearance K990358 · decided 1999-02-26
Clearance details
- K-number
- K990358
- Device name
- CROSS SPORT, RIGID WHEELCHAIR
- Applicant
- Tisport
- Decision
- Substantially Equivalent
- Date received
- 1999-02-05
- Decision date
- 1999-02-26
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- IOR
- Device class
- 1
- Regulation number
- 890.3850
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Kennewick, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| TiLite ZR and ZRA Series 2 are mechanical wheelchairs. Devices are sold under brand name T recall (Z-3161-2011) | TiSport, Llc | 2011-09-07 |