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U.S. Department of Health and Human Services

Product Classification

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Device diathermy, microwave, for use in applying therapeutic deep heat
Regulation Description Microwave diathermy.
Regulation Medical Specialty Physical Medicine
Review Panel Physical Medicine
Product CodeIOA
Premarket Review Office of Neurological and Physical Medicine Devices (OHT5)
Neuromodulation and Rehabilitation Devices (DHT5B)
Submission Type 510(k)
Regulation Number 890.5275
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
Accredited Persons
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