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U.S. Department of Health and Human Services

Product Classification

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Device diathermy, shortwave, for use other than applying therapeutic deep heat
Regulation Description Shortwave diathermy.
Regulation Medical Specialty Physical Medicine
Review Panel Physical Medicine
Product CodeILX
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 890.5290
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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