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Sign in to claim this brandINNOVATION INSTITUTE, LLC
US
Last updated May 25, 2026
What INNOVATION INSTITUTE, LLC makes
The company manufactures surgical pneumatic tourniquet systems for use in orthopedic and vascular procedures, as well as elbow orthoses for post-injury or post-surgical immobilization. Their product line includes single-use cardiopulmonary resuscitation (CPR) masks and reusable non-rebreathing valves, designed for emergency respiratory support. Additionally, they produce blood flow restriction (BFR) cuffs in various sizes for therapeutic applications and a reusable non-rebreathing valve combined with a CPR mask system.
The portfolio includes devices classified under FDA’s Class I and Class II categories, with all products listed in the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States and adheres to applicable U.S. regulatory requirements for medical devices.
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 Innovation Institute, LLC manufacture?
Innovation Institute, LLC produces a range of medical devices including surgical pneumatic tourniquet systems for orthopedic and vascular procedures, elbow orthoses for post-injury or post-surgical immobilization, single-use cardiopulmonary resuscitation (CPR) masks, reusable non-rebreathing valves, and blood flow restriction (BFR) cuffs in multiple sizes for therapeutic use. Their portfolio also includes a reusable non-rebreathing valve combined with a CPR mask system, covering both emergency respiratory support and rehabilitation applications.
Where is Innovation Institute, LLC based, and what regulatory requirements do they follow?
Innovation Institute, LLC is based in the United States. The company develops devices that comply with applicable U.S. regulatory requirements, including those set by the FDA. Their products are designed to meet the standards necessary for their respective classifications, ensuring they align with U.S. medical device regulations.
Which regulatory registries list devices manufactured by Innovation Institute, LLC?
Devices manufactured by Innovation Institute, LLC are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for each product, allowing healthcare providers and regulators to access critical information about the devices, including their identification and classification.
How are devices from Innovation Institute, LLC classified by the FDA?
The FDA classifies devices from Innovation Institute, LLC primarily under Class I and Class II. Class I devices generally pose minimal risk and are subject to general controls, while Class II devices require additional regulations to ensure their safety and effectiveness. The classification depends on the device’s intended use and potential risk to patients, as outlined in the FDA’s regulatory framework.
What is the purpose of the blood flow restriction (BFR) cuffs produced by Innovation Institute, LLC?
The BFR cuffs manufactured by Innovation Institute, LLC are designed for therapeutic applications, specifically to restrict blood flow during rehabilitation exercises. This technique is often used in physical therapy to enhance muscle growth and recovery while minimizing joint stress, particularly in post-injury or post-surgical recovery programs. The cuffs come in various sizes to accommodate different patient needs.
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
- 027184489
Catalogue (11)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Move-D | 3626-90001 | FDA UDI | Class I | Active |
| Move-D Brace, Left | 3626-90015 | FDA UDI | Class I | Active |
| Move-D Brace, Right | 3626-90001 | FDA UDI | Class I | Active |
| LiveBand BFR, Medium Cuff | 3185-90009 | FDA UDI | Class I | Active |
| Big Easy, Non-Rebreathing Valve And Mask | 33-90003 | FDA UDI | Class I | Active |
| LiveBand BFR | 3185-90007 | FDA UDI | Class I | Active |
| LiveBand BFR, Large Cuff | 3185-90010 | FDA UDI | Class I | Active |
| Big Easy, Mask | 33-90004 | FDA UDI | Class I | Active |
| LiveBand BFR, Small Cuff | 3185-90008 | FDA UDI | Class I | Active |
| Big Easy, Non-Rebreathing Valve | 33-90005 | FDA UDI | Class II | Active |
| LiveBand BFR, Extra Large Cuff | 3185-90011 | FDA UDI | Class I | Active |
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