The following data is part of a premarket notification filed by Teh Lin Prosthetic & Orthopaedic, Inc. with the FDA for Teh Lin Power Scooter, Model Tl-822.
| Device ID | K042012 |
| 510k Number | K042012 |
| Device Name: | TEH LIN POWER SCOOTER, MODEL TL-822 |
| Classification | Vehicle, Motorized 3-wheeled |
| Applicant | TEH LIN PROSTHETIC & ORTHOPAEDIC, INC. NO. 58, FU-CHIUN ST. Hsin Chu City, TW 300 |
| Contact | Ke-min Jen |
| Correspondent | Ke-min Jen TEH LIN PROSTHETIC & ORTHOPAEDIC, INC. NO. 58, FU-CHIUN ST. Hsin Chu City, TW 300 |
| Product Code | INI |
| CFR Regulation Number | 890.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-26 |
| Decision Date | 2004-09-24 |
| Summary: | summary |