The following data is part of a premarket notification filed by Teh Lin Prosthetic & Orthopaedic, Inc. with the FDA for Teh Lin Powered Wheelchair, Mdg-601.
| Device ID | K041752 |
| 510k Number | K041752 |
| Device Name: | TEH LIN POWERED WHEELCHAIR, MDG-601 |
| Classification | Wheelchair, Powered |
| Applicant | TEH LIN PROSTHETIC & ORTHOPAEDIC, INC. NO. 58, FU-CHIUN ST. Hsin Chu City, TW 300 |
| Contact | Jen Ke-min |
| Correspondent | Jen Ke-min TEH LIN PROSTHETIC & ORTHOPAEDIC, INC. NO. 58, FU-CHIUN ST. Hsin Chu City, TW 300 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-29 |
| Decision Date | 2004-08-05 |
| Summary: | summary |