FDA Listing

As of December 13, 2019, H+ Cuffs are officially an FDA listed class 1 medical device. 

More information can be found at https://www.fda.gov/

Additionally, H+ Cuff BFR Cuffs are Flexible Spending Account (FSA) and Health Savings Account (HSA) eligible. 
FDA Approved Blood Flow Restriction Cuffs
Comparing BFR Cuffs FDA Listed for Medical Device
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