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U.S. Department of Health and Human Services

Product Classification

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Device stimulator, neuromuscular, external functional
Regulation Description External functional neuromuscular stimulator.
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeGZI
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 882.5810
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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