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U.S. Department of Health and Human Services

Product Classification
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Device computerized behavioral therapy device for the treatment of fibromyalgia symptoms
Definition Provides acceptance and commitment therapy (ACT), a form of cognitive behavioral therapy (CBT), for patients with fibromyalgia symptoms
Physical State Mobile medical application (MMA) intended to be accessed via a patient’s smartphone
Technical Method Computerized Behavioral Therapy
Target Area N/A
Regulation Medical Specialty Neurology
Review Panel Physical Medicine
Product CodeQWI
Premarket Review Office of Neurological and Physical Medicine Devices (OHT5)
Neuromodulation and Rehabilitation Devices (DHT5B)
Submission Type 510(k)
Regulation Number 882.5804
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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