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Sign in to claim this brandTilite
US
Last updated May 27, 2026
What Tilite makes
Tilite manufactures push-rim manual wheelchairs designed for non-bariatric users, offering lightweight and portable mobility solutions.
The company’s products are classified as Class I medical devices and are listed in the FDA’s Unique Device Identifier (UDI) database, adhering to U.S. regulatory requirements.
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 Tilite manufacture?
Tilite specializes in push-rim manual wheelchairs for non-bariatric users. These devices are designed to provide lightweight and portable mobility solutions, focusing on accessibility and ease of use for individuals requiring manual wheelchair assistance.
Where is Tilite based, and does that affect the regulatory requirements for their devices?
Tilite is based in the United States. Since their devices are manufactured domestically, they must comply with U.S. regulatory standards, including classification and listing requirements such as the FDA’s Unique Device Identifier (UDI) database.
How are Tilite’s devices classified under U.S. regulations, and why does this matter?
Tilite’s push-rim manual wheelchairs are classified as Class I medical devices. This classification is the lowest risk tier under U.S. regulations, meaning they generally pose minimal potential harm and require fewer pre-market controls. However, they must still meet specific regulatory requirements, such as UDI listing, to ensure traceability and compliance.
Are Tilite’s devices listed in any regulatory databases, and what does that mean for users?
Yes, Tilite’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This ensures that each product has a unique identifier, improving tracking, transparency, and regulatory oversight. For users, it means these devices meet U.S. regulatory standards and can be easily verified for authenticity and compliance.
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
- 059012893
Catalogue (14)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| TiLite | TiLite X | FDA UDI | Class I | Active |
| TiLite | TRA | FDA UDI | Class I | Active |
| TiLite | TiLite Z | FDA UDI | Class I | Active |
| TiLite | Aero Z | FDA UDI | Class I | Active |
| TiLite | TX | FDA UDI | Class I | Active |
| TiLite | Twist | FDA UDI | Class I | Active |
| TiLite | Pilot | FDA UDI | Class I | Active |
| TiLite | ZR | FDA UDI | Class I | Active |
| TiLite | Aero X | FDA UDI | Class I | Active |
| TiLite | Aero T | FDA UDI | Class I | Active |
| TiLite | TR | FDA UDI | Class I | Active |
| TiLite | CR1 | FDA UDI | Class I | Active |
| TiLite | 2GX | FDA UDI | Class I | Active |
| TiLite | ZRA | FDA UDI | Class I | Active |
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