The following data is part of a premarket notification filed by Comfort Orthopedic Co. Ltd. with the FDA for Comfort Powered Wheelchair, Ly-eb 206.
| Device ID | K072711 |
| 510k Number | K072711 |
| Device Name: | COMFORT POWERED WHEELCHAIR, LY-EB 206 |
| Classification | Wheelchair, Powered |
| Applicant | COMFORT ORTHOPEDIC CO. LTD. NO 58 FU-CHIUN ST. Hsin-chu City, TW |
| Contact | Ke-min Jen |
| Correspondent | Ke-min Jen COMFORT ORTHOPEDIC CO. LTD. NO 58 FU-CHIUN ST. Hsin-chu City, TW |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-25 |
| Decision Date | 2007-10-31 |
| Summary: | summary |