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U.S. Department of Health and Human Services

Product Classification

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Device ultrasonic diathermy for use in applying therapeutic deep heat
Regulation Description Ultrasonic diathermy.
Regulation Medical Specialty Physical Medicine
Review Panel Physical Medicine
Product CodeIMI
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Physical Medicine and Neurotherapueutic Devices Branch (PNDB)
Submission Type 510(k)
Regulation Number 890.5300
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review
Accredited Persons

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