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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cranial motion measurement device
Definition A cranial motion measurement device is a prescription device that utilizes accelerometers to measure the motion or acceleration of the skull. These measurements are not to be used for diagnostic purposes.
Product CodePOP
Regulation Number 882.1630
Device Class 2


Premarket Reviews
ManufacturerDecision
JAN MEDICAL, INC.
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 1

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