Identity
- Trade Name
- Suji BFR FDA UDI
- Generic Name
- Tourniquet cuff, reusable FDA UDI
- Device Name
- Suji device for BFR training. Suji comprises of a BLE enable pump, compression bands and a mobile app. The compression bands are worn at the top of the limb to restrict blood flow during exercise. FDA UDI
- Model / Reference
- V2MDR-01 FDA UDI
- Description
- Suji device for BFR training. Suji comprises of a BLE enable pump, compression bands and a mobile app. The compression bands are worn at the top of the limb to restrict blood flow during exercise. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05070000320403 FDA UDI
- FDA Product Code
- QGX FDA UDI
- GMDN Term
- Tourniquet cuff, reusable 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
No
FDA UDI
Convenience Kit
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Tourniquet cuff, reusable
Suji BFR by Secondperspective Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tourniquet cuff, reusable.
- Color Cuff — Stryker Corp. · Class I
- Vari-Fit Reusable — Delfi Medical Innovations Inc · Class I
- Reusable Conical Cuff — Zhejiang Longyou Lande Medical Technology Co., Ltd. · Class I
- Easi-Fit BFR, Reusable — Delfi Medical Innovations Inc · Class I
- Reusable Tourniquet Cuff — Zhejiang Longyou Lande Medical Technology Co., Ltd. · Class I
- Reusable Tourniquet Cuff — Zhejiang Longyou Lande Medical Technology Co., Ltd. · Class I
- ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP. · Class I
- Vari-Fit Reusable — Delfi Medical Innovations Inc · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Secondperspective Ltd.
Sources (1)
- FDA UDI 54a30b65-a162-4c86-948a-c39c43a945db 33 fields · synced Jun 1, 2026