Suji BFR

GUDID 05070000320403

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.

SECONDPERSPECTIVE LTD.

Tourniquet cuff, reusable
Primary Device ID05070000320403
NIH Device Record Key54a30b65-a162-4c86-948a-c39c43a945db
Commercial Distribution StatusIn Commercial Distribution
Brand NameSuji BFR
Version Model NumberV2MDR-01
Company DUNS223208007
Company NameSECONDPERSPECTIVE LTD.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105070000320403 [Primary]

FDA Product Code

QGXGeneral Use Pneumatic Tourniquet

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-19
Device Publish Date2022-09-09

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