ALL TERRAIN WHEELCHAIR (ATW)
FDA 510(k) clearance K003048 · decided 2000-12-15
Clearance details
- K-number
- K003048
- Device name
- ALL TERRAIN WHEELCHAIR (ATW)
- Applicant
- Roll-Ability (Pty) , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2000-09-29
- Decision date
- 2000-12-15
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- IOR
- Device class
- 1
- Regulation number
- 890.3850
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Roanoke, VA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.