The following data is part of a premarket notification filed by Comfort Orthopedic Co. Ltd. with the FDA for Hero 1, Model Ly-esb220.
| Device ID | K031621 |
| 510k Number | K031621 |
| Device Name: | HERO 1, MODEL LY-ESB220 |
| Classification | Wheelchair, Standup |
| Applicant | COMFORT ORTHOPEDIC CO. LTD. NO. 120 NAN SHIANG TSUEN, SHOEI SHANG SHIANG Chia-yi, TW |
| Contact | Eric H.c. Lee |
| Correspondent | Eric H.c. Lee COMFORT ORTHOPEDIC CO. LTD. NO. 120 NAN SHIANG TSUEN, SHOEI SHANG SHIANG Chia-yi, TW |
| Product Code | IPL |
| CFR Regulation Number | 890.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-23 |
| Decision Date | 2004-01-22 |