FUZE MECHANICAL WHEELCHAIR, MODELS T20 AND T50
FDA 510(k) clearance K063736 · decided 2007-01-17
Clearance details
- K-number
- K063736
- Device name
- FUZE MECHANICAL WHEELCHAIR, MODELS T20 AND T50
- Applicant
- Pdg Product Design Group, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-12-18
- Decision date
- 2007-01-17
- Days to decision
- 30 days
- Clearance type
- Traditional
- Product code
- IOR
- Device class
- 1
- Regulation number
- 890.3850
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Cleveland, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Fuze Manual Tilt Wheelchair. Fuze T50, Fuze T20 and Fuze T50 Jr recall (Z-2695-2014) | Pdg Product Design Group Inc | 2014-09-24 |