The following data is part of a premarket notification filed by Teh Lin Prosthetic & Orthopaedic, Inc. with the FDA for Teh Lin Jupiter Power Chair, Model Tl-320.
| Device ID | K022697 |
| 510k Number | K022697 |
| Device Name: | TEH LIN JUPITER POWER CHAIR, MODEL TL-320 |
| Classification | Wheelchair, Powered |
| 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 | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-13 |
| Decision Date | 2003-01-24 |
| Summary: | summary |