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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 Neuromodulation and Physical Medicine Devices (DHT5B)
Neuromodulation and Physical Medicine Devices (DHT5B)
Submission Type 510(k)
Regulation Number 890.5290
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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