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U.S. Department of Health and Human Services

Product Classification

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Device stimulator, ultrasound and muscle, for use other than applying therapeutic deep
Review Panel Orthopedic
Product CodeLPQ
Premarket Review Stereotaxic, Trauma and Restorative Devices (DHT6C)
Stereotaxic, Trauma and Restorative Devices (DHT6C)
Submission Type PMA
Device Class 3
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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