The following data is part of a premarket notification filed by Comfort Orthopedic Co. Ltd. with the FDA for Comfort Windjoy Scooter, Model Ly-ew302.
| Device ID | K022369 |
| 510k Number | K022369 |
| Device Name: | COMFORT WINDJOY SCOOTER, MODEL LY-EW302 |
| Classification | Vehicle, Motorized 3-wheeled |
| Applicant | COMFORT ORTHOPEDIC CO. LTD. NO.58,FU-CHIUN ST. Hsin-chu City, TW |
| Contact | Jen Ke-min |
| Correspondent | Jen Ke-min COMFORT ORTHOPEDIC CO. LTD. NO.58,FU-CHIUN ST. Hsin-chu City, TW |
| Product Code | INI |
| CFR Regulation Number | 890.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-22 |
| Decision Date | 2002-10-11 |
| Summary: | summary |