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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device wearable vibration device for orthopedic use
Definition A wearable vibration device for orthopedic use is a wearable device that uses mechanical vibrations, targeted to specific regions of the skeleton, to reduce loss of bone strength or bone mineral density.
Product CodeQZO
Regulation Number 888.5895
Device Class 2


Premarket Reviews
ManufacturerDecision
BONE HEALTH TECHNOLOGIES, INC
  GRANTED 1

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