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U.S. Department of Health and Human Services

Product Classification
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Device diathermy, ultrasonic, for use other than applying therapeutic deep heat
Regulation Description Ultrasonic diathermy.
Regulation Medical Specialty Physical Medicine
Review Panel Physical Medicine
Product CodeLXF
Premarket Review Office of Neurological and Physical Medicine Devices (OHT5)
Neuromodulation and Physical Medicine Devices (DHT5B)
Submission Type PMA
Regulation Number 890.5300
Device Class 3
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 Standards
Third Party Review Not Third Party Eligible
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