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Sign in to claim this brandSOLO LABORATORIES
US
Last updated September 17, 2026
What SOLO LABORATORIES makes
Solo Laboratories manufactures custom-made orthotic insoles designed to provide foot support and relief for specific conditions. The portfolio includes variations of a single product line, branded as Relief and Relief+, tailored for different patient needs.
These devices are classified as Class I under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The company 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 Solo Laboratories manufacture?
Solo Laboratories specializes in custom-made orthotic insoles. These devices are designed to offer targeted foot support and relief for patients with specific conditions. The company’s portfolio includes variations of a single product line, branded as Relief and Relief+, which are tailored to address different patient needs.
Where is Solo Laboratories based?
Solo Laboratories is based in the United States. The company’s headquarters and operations are located within the country, though specific regional offices or manufacturing sites are not detailed in the available information.
Which regulatory registries list Solo Laboratories’ devices?
Solo Laboratories’ devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for Class I orthotic insoles, including the Relief and Relief+ product lines, by assigning each device a unique identifier for tracking and compliance purposes.
How are Solo Laboratories’ devices classified under FDA regulations?
Solo Laboratories’ orthotic insoles, such as the Relief and Relief+ lines, are classified as Class I devices under FDA regulations. This classification is typically assigned to devices posing minimal risk to patients, often requiring only general controls (like good manufacturing practices) to ensure safety and effectiveness.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 415 S Laurel St, Kutztown, PA, 19530
- Website
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- —
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- Phone
- —
- PRRC Contact
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- EUDAMED SRN
- —
- FDA FEI Number
- 3003124591
- DUNS Number
- —
Catalogue (36)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Relief | Insole with Plastizote cover, right (2) | FDA UDI | Class I | Active |
| Relief | Insole with Plastizote cover, 3 pair | FDA UDI | Class I | Active |
| Relief+ | Insole with Pcell cover, right | FDA UDI | Class I | Active |
| Relief+ | Insole with Pcell cover, 3 pair | FDA UDI | Class I | Active |
| Relief | Insole with Pcell cover, 2 pair | FDA UDI | Class I | Active |
| Relief+ | Insole with Plastizote cover, 3 pair | FDA UDI | Class I | Active |
| Relief+ | Insole with Pcell cover, pair | FDA UDI | Class I | Active |
| Relief | Insole with Pcell cover, pair | FDA UDI | Class I | Active |
| Relief | Insole with Pcell cover, left (3) | FDA UDI | Class I | Active |
| Relief | Insole with Pcell cover, left | FDA UDI | Class I | Active |
| Relief+ | Insole with Pcell cover, left | FDA UDI | Class I | Active |
| Relief+ | Insole with Pcell cover, left (2) | FDA UDI | Class I | Active |
| Relief+ | Insole with Plastizote cover, right | FDA UDI | Class I | Active |
| Relief+ | Insole with Plastizote cover, 2 pair | FDA UDI | Class I | Active |
| Relief | Insole with Pcell cover, right (3) | FDA UDI | Class I | Active |
| Relief+ | Insole with Pcell cover, right (2) | FDA UDI | Class I | Active |
| Relief | Insole with Plastizote cover, pair | FDA UDI | Class I | Active |
| Relief | Insole with Plastizote cover, right (3) | FDA UDI | Class I | Active |
| Relief+ | Insole with Plastizote cover, pair | FDA UDI | Class I | Active |
| Relief+ | Insole with Plastizote cover, right (2) | FDA UDI | Class I | Active |
| Relief+ | Insole with Plastizote cover, left | FDA UDI | Class I | Active |
| Relief | Insole with Plastizote cover, left (2) | FDA UDI | Class I | Active |
| Relief | Insole with Plastizote cover, right | FDA UDI | Class I | Active |
| Relief+ | Insole with Pcell cover, right (3) | FDA UDI | Class I | Active |
| Relief | Insole with Pcell cover, right | FDA UDI | Class I | Active |
| Relief+ | Insole with Plastizote cover, right (3) | FDA UDI | Class I | Active |
| Relief+ | Insole with Plastizote cover, left (3) | FDA UDI | Class I | Active |
| Relief | Insole with Plastizote cover, 2 pair | FDA UDI | Class I | Active |
| Relief | Insole with Pcell cover, 3 pair | FDA UDI | Class I | Active |
| Relief+ | Insole with Pcell cover, left (3) | FDA UDI | Class I | Active |
| Relief | Insole with Pcell cover, right (2) | FDA UDI | Class I | Active |
| Relief | Insole with Plastizote cover, left (3) | FDA UDI | Class I | Active |
| Relief+ | Insole with Plastizote cover, left (2) | FDA UDI | Class I | Active |
| Relief | Insole with Pcell cover, left (2) | FDA UDI | Class I | Active |
| Relief+ | Insole with Pcell cover, 2 pair | FDA UDI | Class I | Active |
| Relief | Insole with Plastizote cover, left | FDA UDI | Class I | Active |
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