Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Teh Lin Prosthetic & Orthopaedic, Inc. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
60 daysmedian FDA review time
178 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K051116 | MODEL TL-560 POWER SCOOTER | Teh Lin Prosthetic & Orthopaedic, Inc. | 2005-05-31 | 29 | 0 |
| K051118 | MODEL TL-360 POWER SCOOTER | Teh Lin Prosthetic & Orthopaedic, Inc. | 2005-05-31 | 29 | 0 |
| K042012 | TEH LIN POWER SCOOTER, MODEL TL-822 | Teh Lin Prosthetic & Orthopaedic, Inc. | 2004-09-24 | 60 | 0 |
| K042011 | POWER SCOOTER, MODEL TL0821 | Teh Lin Prosthetic & Orthopaedic, Inc. | 2004-09-24 | 60 | 0 |
| K042010 | POWER SCOOTER, MODEL TL-688 | Teh Lin Prosthetic & Orthopaedic, Inc. | 2004-09-01 | 37 | 0 |
| K041752 | TEH LIN POWERED WHEELCHAIR, MDG-601 | Teh Lin Prosthetic & Orthopaedic, Inc. | 2004-08-05 | 37 | 0 |
| K022696 | TEH LIN POWERED WHEELCHAIR, MODEL MDG-201 | Teh Lin Prosthetic & Orthopaedic, Inc. | 2003-02-07 | 178 | 0 |
| K022697 | TEH LIN JUPITER POWER CHAIR, MODEL TL-320 | Teh Lin Prosthetic & Orthopaedic, Inc. | 2003-01-24 | 164 | 0 |
| K022698 | SCOOTER MARS SERIES, MODEL TL-588 | Teh Lin Prosthetic & Orthopaedic, Inc. | 2002-12-02 | 111 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda