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U.S. Department of Health and Human Services

Product Classification
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Device virtual reality behavioral therapy device for pain relief
Regulation Description Virtual reality behavioral therapy device for pain relief.
Definition A virtual reality behavioral therapy device for pain relief is a device intended to provide behavioral therapy for patients with pain. Therapy is administered via a virtual reality display which utilizes a software program containing the behavioral therapy content.
Physical State Virtual reality display, software
Technical Method Uses a virtual reality display to provide behavioral based treatment to patients with chronic pain by modifying the patient’s thinking and behavioral patterns
Target Area Areas of pain
Regulation Medical Specialty Neurology
Review Panel Physical Medicine
Product CodeQRA
Premarket Review Office of Neurological and Physical Medicine Devices (OHT5)
Neuromodulation and Physical Medicine Devices (DHT5B)
Submission Type 510(k)
Regulation Number 890.5800
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
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
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