The following data is part of a premarket notification filed by Comfort Orthopedic Co. Ltd. with the FDA for Comfort Wheelchairs.
| Device ID | K020451 |
| 510k Number | K020451 |
| Device Name: | COMFORT WHEELCHAIRS |
| Classification | Wheelchair, Mechanical |
| Applicant | COMFORT ORTHOPEDIC CO. LTD. NO. 120 NAN SHIANG TSUEN, SHOEI SHANG SHIANG Chia-yi, TW |
| Contact | Eric Lee |
| Correspondent | Eric Lee COMFORT ORTHOPEDIC CO. LTD. NO. 120 NAN SHIANG TSUEN, SHOEI SHANG SHIANG Chia-yi, TW |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-11 |
| Decision Date | 2002-03-14 |