A & I Pediatric Wheelchairs, Models Rwal2006-12, Lt3207-12. a & I Bariatric Wheelchairs, Model No. Wcde2611p, Wcde2811p
K052586 is the FDA 510(k) clearance record for A & I PEDIATRIC WHEELCHAIRS, MODELS RWAL2006-12, LT3207-12. A & I BARIATRIC WHEELCHAIRS, MODEL NO. WCDE2611P, WCDE2811P, a class I device, cleared for Taiwan an I Co., Ltd. on under FDA product code IOR (Wheelchair, Mechanical). FDA's definition for product code IOR reads: "A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. FDA interprets “mobility to persons restricted to a sitting position”...". FDA records list 2 510(k) clearances for Taiwan an I Co., Ltd., from to . As of , FDA records show no recalls naming K052586.
Clearance record
- Decision date
- Received
- (80 days to decision)
- Product code
- IOR Wheelchair, Mechanical
- Regulation
- 21 CFR 890.3850
- Device class
- Class I
- Review panel
- Physical Medicine
- Applicant
- Taiwan an I Co., Ltd. 13 Red Fox Ln., Littleton CO
- 510(k) summary
- Statement
- Third party review
- No
Clearances, product code IOR
Trailing 12 monthsShow the numbers
| Month | Clearances |
|---|---|
| November 2025 | 2 |
| December 2025 | 2 |
| January 2026 | 2 |
| February 2026 | 0 |
| March 2026 | 1 |
| April 2026 | 1 |
| May 2026 | 2 |
| June 2026 | 4 |
| July 2026 | 1 |
| August 2026 | 1 |
| September 2026 | 5 |
| October 2026 | 0 |
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