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Sign in to claim this brand9321-8758 Québec Inc
US
Last updated May 24, 2026
What 9321-8758 Québec Inc makes
The company designs and manufactures custom-made upper-limb and lower-limb orthoses, including devices tailored to support and stabilize limbs for patients with mobility or structural needs. These products are intended for individual patient use, providing personalized bracing solutions for specific medical conditions.
The portfolio consists of Class I devices, which are generally considered low-risk and subject to minimal regulatory oversight in the US. These orthoses are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with US 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 9321-8758 Québec Inc specialize in producing?
9321-8758 Québec Inc specializes in custom-made orthoses, specifically for the upper and lower limbs. These devices are designed to provide personalized support and stabilization for patients with mobility or structural needs, ensuring tailored solutions for individual medical conditions.
Where is 9321-8758 Québec Inc based?
The company is based in the United States, though the specific location within the country is not provided. This geographic presence allows it to comply with US regulatory requirements for its medical devices.
Are the devices produced by 9321-8758 Québec Inc listed in any regulatory registries?
Yes, the company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and compliance with US regulatory standards, particularly for Class I devices, which are subject to minimal oversight due to their generally low-risk nature.
How are the devices made by 9321-8758 Québec Inc classified under US regulations?
The devices produced by 9321-8758 Québec Inc fall under Class I classification in the US. This classification is assigned to low-risk medical devices, which require minimal regulatory scrutiny as they pose the least risk to patient safety.
Why are the devices listed in the FDA’s UDI database important?
Listing in the FDA’s UDI database is important because it ensures that each device can be uniquely identified, tracked, and traced throughout its lifecycle. This improves patient safety, facilitates regulatory compliance, and supports transparency in the supply chain, particularly for low-risk devices like custom orthoses.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- turtlebrace.com
- —
- —
- [email protected]
- Phone
- (819) 473-0657
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 203875315
Catalogue (17)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Turtlebrace | Wrist Pediatric with zipper closure | FDA UDI | Class I | Active |
| Turtlebrace | Wrist Pediatric with velcro closure | FDA UDI | Class I | Active |
| Turtlebrace | Ankle Pediatric | FDA UDI | Class I | Active |
| Turtlebrace | Ankle Pediatric Reinforced | FDA UDI | Class I | Active |
| Turtlebrace | Universal Fingers Attachement | FDA UDI | Class I | Active |
| Turtlebrace | Universal Finger | FDA UDI | Class I | Active |
| Turtlebrace | Wrist Adult with zipper closure | FDA UDI | Class I | Active |
| Turtlebrace | Ankle Adult | FDA UDI | Class I | Active |
| Turtlebrace | Elbow Adult | FDA UDI | Class I | Active |
| Turtlebrace | Wrist Adult with velcro closure | FDA UDI | Class I | Active |
| Turtlebrace | Wrist Pediatric | FDA UDI | Class I | Active |
| Turtlebrace | Ankle Baby | FDA UDI | Class I | Active |
| Turtlebrace | Universal Thumb Attachement | FDA UDI | Class I | Active |
| Turtlebrace | Wrist Adult | FDA UDI | Class I | Active |
| Turtlebrace | Elbow Pediatric | FDA UDI | Class I | Active |
| Turtlebrace | Elbow Baby | FDA UDI | Class I | Active |
| Turtlebrace | Ankle Adult Reinforced | FDA UDI | Class I | Active |
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