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U.S. Department of Health and Human Services

Product Classification

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Device cranial motion measurement device
Regulation Description 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.
Physical State Accelerometer hardware. May include headset to aid in positioning. May include additional sensors (e.g. photoplethysmography). May include hardware and software to allow for data collection and review. Does not include software that outputs any clinical interpretation of the data.
Technical Method Uses a headset containing accelerometers positioned around the head to measure motion or acceleration, and may use a photoplethysmography sensor to detect heartbeat.
Target Area Head
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodePOP
Premarket Review Neurological and Physical Medicine Devices (OHT5)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Submission Type 510(k)
Regulation Number 882.1630
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
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