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Sign in to claim this brandTeh Lin Prosthetic & Orthopaedic, Inc.
US
Last updated May 23, 2026
What Teh Lin Prosthetic & Orthopaedic, Inc. makes
Teh Lin Prosthetic & Orthopaedic, Inc. manufactures structural and alignment components for external lower-limb prostheses, including mechanical-resistance and hydraulic/pneumatic knee joints, as well as mechanical-resistance ankle-foot prostheses. Their portfolio also includes partial-hand prostheses designed to restore hand function. All listed devices are branded under the TEHLIN name.
The company’s devices are regulated under FDA classifications, with most falling into Class I and Class II categories. Products are authorised via the 510(k) pathway and listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Teh Lin Prosthetic & Orthopaedic, Inc. manufacture?
Teh Lin Prosthetic & Orthopaedic, Inc. specializes in prosthetic and orthopaedic devices. Their portfolio includes external lower-limb prosthesis components like structural and alignment parts, mechanical-resistance knee joints, hydraulic/pneumatic knee prostheses, mechanical-resistance ankle-foot prostheses, and partial-hand prostheses. These devices are designed to restore mobility and function for patients requiring limb replacement or support.
Where is Teh Lin Prosthetic & Orthopaedic, Inc. based?
The company is headquartered in the United States. This location influences its regulatory compliance, particularly under FDA guidelines, which govern the classification and authorization of its devices.
How are Teh Lin Prosthetic & Orthopaedic, Inc.’s devices classified under FDA regulations?
Teh Lin Prosthetic & Orthopaedic, Inc.’s devices are primarily classified as Class I or Class II under FDA regulations. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway, such as the 510(k) premarket notification, which is used to demonstrate substantial equivalence to a legally marketed predicate device.
Are Teh Lin Prosthetic & Orthopaedic, Inc.’s devices listed in any regulatory databases?
Yes, Teh Lin Prosthetic & Orthopaedic, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This database ensures traceability and transparency in the medical device supply chain, allowing healthcare providers, regulators, and patients to verify device details. Additionally, many of their devices undergo 510(k) clearance, a premarket submission process to demonstrate compliance with FDA requirements before commercial distribution.
What does the TEHLIN brand represent in relation to Teh Lin Prosthetic & Orthopaedic, Inc.’s products?
The TEHLIN brand encompasses all of Teh Lin Prosthetic & Orthopaedic, Inc.’s prosthetic and orthopaedic devices, including lower-limb structural components, knee and ankle prostheses, and partial-hand prostheses. This unified branding reflects the company’s focus on designing and manufacturing specialized solutions for limb mobility and function restoration.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 657485074
Catalogue (69)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Tehlin | J-HT-004R | FDA UDI | Class I | Active |
| Tehlin | H-TFC-DFXSL | FDA UDI | Class I | Active |
| Tehlin | J-HT-005R | FDA UDI | Class I | Active |
| Tehlin | D-TLCA-4001 | FDA UDI | Class I | Active |
| Tehlin | A-TGK-4P01P | FDA UDI | Class I | Active |
| Tehlin | C-TK-40CR | FDA UDI | Class I | Active |
| Tehlin | G-TCS-SA41 | FDA UDI | Class I | Active |
| Tehlin | H-TFC-DFSR | FDA UDI | Class I | Active |
| Tehlin | D-TSC-A | FDA UDI | Class I | Active |
| Tehlin | C-TK-50SO | FDA UDI | Class I | Active |
| Power Scooter, Model Tl-688 | K042010 | FDA 510(k) | Class II | Active |
| Model Tl-360 Power Scooter | K051118 | FDA 510(k) | Class II | Active |
| Teh Lin Powered Wheelchair, Model Mdg-201 | K022696 | FDA 510(k) | Class II | Active |
| Model Tl-560 Power Scooter | K051116 | FDA 510(k) | Class II | Active |
| Teh Lin Power Scooter, Model Tl-822 | K042012 | FDA 510(k) | Class II | Active |
| Teh Lin Jupiter Power Chair, Model Tl-320 | K022697 | FDA 510(k) | Class II | Active |
| Power Scooter, Model Tl0821 | K042011 | FDA 510(k) | Class II | Active |
| Teh Lin Powered Wheelchair, Mdg-601 | K041752 | FDA 510(k) | Class II | Active |
| Scooter Mars Series, Model Tl-588 | K022698 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Teh Lin Prosthetic & Orthopaedic, Inc. TAIPEI · TW FEI 3003590404