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U.S. Department of Health and Human Services

Product Classification
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Device computerized behavioral therapy device for migraine
Definition A computerized behavioral therapy device for headache is a prescription device intended to provide a computerized version of behavioral therapy for the treatment of headache.
Physical State Software
Technical Method Software prompted modules and skills
Target Area Intended to treat behaviors through brain
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeSEE
Premarket Review Neuromodulation and Physical Medicine Devices (DHT5B)
Neuromodulation and Physical Medicine Devices (DHT5B)
Submission Type 510(k)
Regulation Number 882.5806
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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