Teh Lin Prosthetic & Orthopaedic, Inc.
Taipei, TW
TEH LIN PROSTHETIC & ORTHOPAEDIC, INC. appears in FDA device records in Taipei, TW. FDA records list 9 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 9 510(k) clearances for Teh Lin Prosthetic & Orthopaedic, Inc. between 2002 and 2005. The busiest year on record is 2004, with 4. The most recent is 2005, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2002 | 1 |
| 2003 | 2 |
| 2004 | 4 |
| 2005 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K051118 | MODEL TL-360 POWER SCOOTER | INI | Substantially Equivalent | |
| K051116 | MODEL TL-560 POWER SCOOTER | INI | Substantially Equivalent | |
| K042012 | TEH LIN POWER SCOOTER, MODEL TL-822 | INI | Substantially Equivalent | |
| K042011 | POWER SCOOTER, MODEL TL0821 | INI | Substantially Equivalent | |
| K042010 | POWER SCOOTER, MODEL TL-688 | INI | Substantially Equivalent | |
| K041752 | TEH LIN POWERED WHEELCHAIR, MDG-601 | ITI | Substantially Equivalent | |
| K022696 | TEH LIN POWERED WHEELCHAIR, MODEL MDG-201 | ITI | Substantially Equivalent | |
| K022697 | TEH LIN JUPITER POWER CHAIR, MODEL TL-320 | ITI | Substantially Equivalent | |
| K022698 | SCOOTER MARS SERIES, MODEL TL-588 | INI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9617046 | 3003590404 | TEH LIN PROSTHETIC & ORTHOPAEDIC, INC. | NO. 7, WU CHUAN 7TH ROAD, TAIPEI 248 TW | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- ISHComponent, External, Limb, Ankle/Foot
- IRAHand, External Limb Component, Mechanical
- IQZHand, External Limb Component, Powered
- IQXHook, External Limb Component, Mechanical
- ISYJoint, Knee, External Limb Component
- IQQJoint, Shoulder, External Limb Component
- ISZUnit, Wrist, External Limb Component, Mechanical
- INIVehicle, Motorized 3-Wheeled
- ITIWheelchair, Powered
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain