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U.S. Department of Health and Human Services

Product Classification

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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.
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 Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Neurodiagnostic and Neurosurgical Devices Branch (NDNB)
Submission Type 510(k)
Regulation Number 882.1630
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review