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U.S. Department of Health and Human Services

Product Classification
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Device thermal system for insomnia
Regulation Description Thermal system for insomnia.
Definition A thermal system for insomnia is a prescription device for use in patients with insomnia that is used to apply a specified temperature to the skin surface.
Physical State Applies a specified temperature to the skin surface in patients with insomnia.
Technical Method Applies a specified temperature to the skin surface in patients with insomnia.
Target Area Skin surface.
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodePLU
Premarket Review Office of Neurological and Physical Medicine Devices (OHT5)
Neuromodulation and Rehabilitation Devices (DHT5B)
Submission Type 510(k)
Regulation Number 882.5700
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 Not Third Party Eligible
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