STORM TDX POWER WHEELCHAIR
FDA 510(k) clearance K023589 · decided 2002-11-19
Clearance details
- K-number
- K023589
- Device name
- STORM TDX POWER WHEELCHAIR
- Applicant
- Invacare Corp.
- Decision
- Substantially Equivalent
- Date received
- 2002-10-25
- Decision date
- 2002-11-19
- Days to decision
- 25 days
- Clearance type
- Traditional
- Product code
- ITI
- Device class
- 2
- Regulation number
- 890.3860
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Elyria, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| TDX Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power wheelchairs recall (Z-1137-2015) | Invacare Corporation | 2015-02-20 |
| Invacare Power Wheelchair, one per box To provide mobility to a person restricted to a sit recall (Z-2270-2013) | Invacare Corporation | 2013-09-23 |
| TDX SP Power Wheelchair, TDX SR Power Wheelchair, TDX SI Power Wheelchair. Model Number(s) recall (Z-1905-2012) | Invacare Corporation | 2012-06-29 |
| TDX SP Power Wheelchair, Model #'s: TDXSP-CG, TDXSP-CG-GT, TDXSP-MCG, TDXSP-MCG-GT, Distri recall (Z-1201-2012) | Invacare Corporation | 2012-03-12 |
| Invacare Storm TDX SR Power Wheelchair with Stability Lock Model numbers: TDXSR, TDXSR-CG, recall (Z-0579-2010) | Invacare Corporation | 2009-12-29 |
| Invacare Storm TDX SP Power Wheelchair with Stability Lock, Model numbers: TDXSP, TDXSP-CG recall (Z-0930-2009) | Invacare Corporation | 2009-01-27 |
| Invacare Storm TDX Power Wheelchair, Models: #TDX3-PS, TDX3-SE-PS, TDX4-PS. recall (Z-0966-2007) | Invacare Corporation | 2007-07-04 |