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U.S. Department of Health and Human Services

Product Classification

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Device stationary ultrasonic diathermy device for use in applying therapeutic deep heat
Regulation Description Ultrasonic diathermy.
Definition Ultrasonic diathermy devices which include stationary applicators enabling hands-free operation.
Physical State Ultrasonic diathermy devices which include stationary applicators enabling hands-free operation.
Technical Method The device uses ultrasonic energy to produce deep heat within the body.
Target Area To be applied over body areas such as the shoulder and knee; however, the device should not be applied directly over bone that is near the skin surface.
Regulation Medical Specialty Physical Medicine
Review Panel Physical Medicine
Product CodePFW
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
Third Party Review Not Third Party Eligible
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