The following data is part of a premarket notification filed by Taiwan An I Co.,ltd. with the FDA for A & I Wheelchairs.
| Device ID | K010094 |
| 510k Number | K010094 |
| Device Name: | A & I WHEELCHAIRS |
| Classification | Wheelchair, Mechanical |
| Applicant | TAIWAN AN I CO.,LTD. NO.1 BEEN TING BEEN-TSUOH VILLAGE, SHI-KOOU SHIANG Chia-yi Shiann, TW |
| Contact | Ani Hwong |
| Correspondent | Ani Hwong TAIWAN AN I CO.,LTD. NO.1 BEEN TING BEEN-TSUOH VILLAGE, SHI-KOOU SHIANG Chia-yi Shiann, TW |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-11 |
| Decision Date | 2001-02-15 |