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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device biofeedback for adjunctive treatment of symptoms associated with stress and anxiety
Regulation Description Biofeedback device.
Definition A biofeedback device for adjunctive treatment of patient-reported symptoms associated with stress and anxiety is intended to provide feedback to users with patient-reported symptoms associated with stress and anxiety on a physiological measurement as a relaxation treatment for the reduction of stress and anxiety.
Product CodeSEN
Regulation Number 882.5050
Device Class 2


Premarket Reviews
ManufacturerDecision
FREESPIRA, INC.
  SUBSTANTIALLY EQUIVALENT 1

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