The following data is part of a premarket notification filed by Comfort Orthopedic Co. Ltd. with the FDA for Comfort Standing Wheelchair, Hero Series.
| Device ID | K102734 |
| 510k Number | K102734 |
| Device Name: | COMFORT STANDING WHEELCHAIR, HERO SERIES |
| Classification | Wheelchair, Standup |
| Applicant | COMFORT ORTHOPEDIC CO. LTD. 2064 TAMARIN DRIVE Columbus, OH 43235 |
| Contact | Jen Ke-min |
| Correspondent | Jen Ke-min COMFORT ORTHOPEDIC CO. LTD. 2064 TAMARIN DRIVE Columbus, OH 43235 |
| Product Code | IPL |
| CFR Regulation Number | 890.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-22 |
| Decision Date | 2010-12-14 |
| Summary: | summary |