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U.S. Department of Health and Human Services

Product Classification

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Device peripheral electromagnetic field (pemf) to aid wound healing
Review Panel Physical Medicine
Product CodeMBQ
Premarket Review Neuromodulation and Physical Medicine Devices (DHT5B)
Neuromodulation and Physical Medicine Devices (DHT5B)
Submission Type Contact ODE
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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