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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device diabetes digital therapeutic device
Definition A diabetes digital behavioral therapeutic device is a prescription use software device that provides digital behavioral therapy to aid in the management of diabetes. This device is intended to provide limited secondary benefit to patients with diabetes mellitus by assisting them in managing their condition. This device is not intended to replace any primary treatment, such as diet/lifestyle changes or medication.
Product CodeQXC
Regulation Number 880.5735
Device Class 2


Premarket Reviews
ManufacturerDecision
BETTER THERAPEUTICS
  GRANTED 1

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