Identity
- Trade Name
- LiveBand BFR FDA UDI
- Generic Name
- Surgical pneumatic tourniquet system FDA UDI
- Device Name
- The LiveBand Blood Flow Restriction System is a portable and user-friendly Blood Flow Restriction device. BFR training is clinically proven to increase muscle strength and aid in physical and rehabilitation therapy, while reducing the weight load on joints. LiveBand BFR uses a proprietary system to actively manage and maintain the desired limb occlusion pressure, customized for each patient. FDA UDI
- Model / Reference
- 3185-90007 FDA UDI
- Description
- The LiveBand Blood Flow Restriction System is a portable and user-friendly Blood Flow Restriction device. BFR training is clinically proven to increase muscle strength and aid in physical and rehabilitation therapy, while reducing the weight load on joints. LiveBand BFR uses a proprietary system to actively manage and maintain the desired limb occlusion pressure, customized for each patient. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850055775077 FDA UDI
- FDA Product Code
- KCY FDA UDI
- GMDN Term
- Surgical pneumatic tourniquet system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.5910 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical pneumatic tourniquet system
LiveBand BFR by Innovation Institute, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- A.T.S.® Personalized Pressure® — Zimmer Orthopaedic Surgical Products · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Innovation Institute, Llc
Sources (1)
- FDA UDI f47d45a1-32cd-4adc-b1a1-e485f8b43e95 33 fields · synced May 30, 2026