The following data is part of a premarket notification filed by Comfort Orthopedic Co. Ltd. with the FDA for Comfort Scooter, Model Ly-ew415.
| Device ID | K063032 |
| 510k Number | K063032 |
| Device Name: | COMFORT SCOOTER, MODEL LY-EW415 |
| Classification | Vehicle, Motorized 3-wheeled |
| Applicant | COMFORT ORTHOPEDIC CO. LTD. NO.58,FU-CHIUN ST. Hsin-chu City, TW 30067 |
| Contact | Ke-min Jen |
| Correspondent | Ke-min Jen COMFORT ORTHOPEDIC CO. LTD. NO.58,FU-CHIUN ST. Hsin-chu City, TW 30067 |
| Product Code | INI |
| CFR Regulation Number | 890.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-03 |
| Decision Date | 2006-10-16 |
| Summary: | summary |