Suji BFR

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…

Registry build 21.09.26

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.

5manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Zhejiang (1), Shanghai (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code QGX
Manufacturer City Province Registered as Device types
Vistar Medical Supplies Co., Ltd. Shenzhen Guangdong Contract manufacturer 11
Ningbo Risenmed Technology Co., Ltd. Ningbo Zhejiang Contract manufacturer 42
Shanghai Dynamic Medical Supplies Co., Ltd. Shanghai Shanghai Contract manufacturer 37
Kossel Medtech (Suzhou) Co., Ltd. Suzhou Jiangsu Manufacturer 4
Auckland Medical Technology (Sichuan) Co., Ltd. Luzhou Sichuan Manufacturer 3

Record

Regulatory record for Suji BFR
Listed by SecondPerspective, Ltd., United Kingdom
FDA product code QGX
Device type General Use Pneumatic Tourniquet
Device class Class 1
Regulation 21 CFR 878.5910
Establishment Specification developer, Manufacturer
Premarket notification Exempt
Record published 2022-09-09

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries lot or batch number, manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Suji BFR
Catalogue number Size Status
V2MDR-01 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Resilient Medical Solutions Resilient Medical Solutions, LLC 7
The Quick-T tourniquet First Care Products Ltd. 1
Quick-T First Care Products Ltd. 1

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer