The following data is part of a premarket notification filed by Taiwan An I Co.,ltd. with the FDA for A & I Pediatric Wheelchairs, Models Rwal2006-12, Lt3207-12. A & I Bariatric Wheelchairs, Model No. Wcde2611p, Wcde2811p.
| Device ID | K052586 |
| 510k Number | K052586 |
| Device Name: | A & I PEDIATRIC WHEELCHAIRS, MODELS RWAL2006-12, LT3207-12. A & I BARIATRIC WHEELCHAIRS, MODEL NO. WCDE2611P, WCDE2811P |
| Classification | Wheelchair, Mechanical |
| Applicant | TAIWAN AN I CO.,LTD. 13 RED FOX LANE Littleton, CO 80127 |
| Contact | Kevin Walls |
| Correspondent | Kevin Walls TAIWAN AN I CO.,LTD. 13 RED FOX LANE Littleton, CO 80127 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-20 |
| Decision Date | 2005-12-09 |