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US
Last updated May 27, 2026
What SPEX LIMITED makes
The company designs and manufactures wheelchair accessories, including seat cushions, back rests, prefabricated head/trunk supports, occupant restraints, and headrests for wheelchairs and standers. These products are intended to enhance comfort, support, and safety for users in seated or transitional positions.
All listed devices fall under Class I regulation and are registered in the FDA’s Unique Device Identifier (UDI) database. The company’s products are based in the United States and comply with applicable U.S. regulatory requirements for these categories.
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 Spex Limited manufacture?
Spex Limited specializes in wheelchair accessories designed to improve user comfort, support, and safety. Their product range includes seat cushions, back rests, prefabricated head/trunk supports, occupant restraints, and headrests for wheelchairs and standers. These devices are intended for users who require additional support during seated or transitional activities.
Where is Spex Limited based, and what regulatory requirements do their devices comply with?
Spex Limited is based in the United States. Their devices are developed and manufactured in compliance with applicable U.S. regulatory standards, ensuring they meet the necessary requirements for their intended use categories.
Which regulatory registries list Spex Limited’s devices?
Spex Limited’s devices are registered in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify their Class I medical devices, ensuring transparency and traceability in the healthcare supply chain.
How are Spex Limited’s devices classified under U.S. regulations?
All of Spex Limited’s listed devices fall under Class I regulation in the U.S. This classification applies to low-risk devices that pose minimal potential harm to users, allowing for streamlined oversight while still ensuring compliance with safety and performance standards.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- spexseating.com
- —
- —
- [email protected]
- Phone
- +64330079790
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 748649195
Catalogue (506)
Page 11 of 11| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Spex Limited | 1156-1016-400 | FDA UDI | Class I | Active |
| Spex Limited | 1255-1718-0SS-C | FDA UDI | Class I | Active |
| Spex Limited | 1102-1820-00SC | FDA UDI | Class I | Active |
| Spex Limited | 1102-2022-1CSC | FDA UDI | Class I | Active |
| Spex Limited | 1102-1216-WSC-C_077 | FDA UDI | Class I | Active |
| Spex Limited | 1102-1414-1CSC | FDA UDI | Class I | Active |
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