A & I PEDIATRIC WHEELCHAIRS, MODELS RWAL2006-12, LT3207-12. A & I BARIATRIC WHEELCHAIRS, MODEL NO. WCDE2611P, WCDE2811P
FDA 510(k) clearance K052586 · decided 2005-12-09
Clearance details
- K-number
- K052586
- Device name
- A & I PEDIATRIC WHEELCHAIRS, MODELS RWAL2006-12, LT3207-12. A & I BARIATRIC WHEELCHAIRS, MODEL NO. WCDE2611P, WCDE2811P
- Applicant
- Taiwan an I Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2005-09-20
- Decision date
- 2005-12-09
- Days to decision
- 80 days
- Clearance type
- Traditional
- Product code
- IOR
- Device class
- 1
- Regulation number
- 890.3850
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Littleton, CO, 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.