Teh Lin Prosthetic & Orthopaedic, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Teh Lin Prosthetic & Orthopaedic, Inc.” (first 2002, latest 2005), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 60 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| INI | Vehicle, Motorized 3-Wheeled | 6 | 6 |
| ITI | Wheelchair, Powered | 3 | 3 |
Review panels
Most recent Teh Lin Prosthetic & Orthopaedic, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K051118 | MODEL TL-360 POWER SCOOTER | INI | 2005-05-31 | 29 |
| K051116 | MODEL TL-560 POWER SCOOTER | INI | 2005-05-31 | 29 |
| K042012 | TEH LIN POWER SCOOTER, MODEL TL-822 | INI | 2004-09-24 | 60 |
| K042011 | POWER SCOOTER, MODEL TL0821 | INI | 2004-09-24 | 60 |
| K042010 | POWER SCOOTER, MODEL TL-688 | INI | 2004-09-01 | 37 |
| K041752 | TEH LIN POWERED WHEELCHAIR, MDG-601 | ITI | 2004-08-05 | 37 |
| K022696 | TEH LIN POWERED WHEELCHAIR, MODEL MDG-201 | ITI | 2003-02-07 | 178 |
| K022697 | TEH LIN JUPITER POWER CHAIR, MODEL TL-320 | ITI | 2003-01-24 | 164 |
| K022698 | SCOOTER MARS SERIES, MODEL TL-588 | INI | 2002-12-02 | 111 |
Recalls
openFDA lists no recalls under a recalling firm named Teh Lin Prosthetic & Orthopaedic, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Teh Lin Prosthetic & Orthopaedic, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Teh Lin Prosthetic & Orthopaedic, Inc.” (first 2002, latest 2005), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Teh Lin Prosthetic & Orthopaedic, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Teh Lin Prosthetic & Orthopaedic, Inc. is 60 days.
Which FDA product codes appear under Teh Lin Prosthetic & Orthopaedic, Inc.?
The most frequent FDA product codes under this applicant name are INI (Vehicle, Motorized 3-Wheeled, 6); ITI (Wheelchair, Powered, 3).
Next steps
- See all 9 Teh Lin Prosthetic & Orthopaedic, Inc. clearances with predicates and recalls
- Run predicate analysis for product code INI, Teh Lin Prosthetic & Orthopaedic, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.