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U.S. Department of Health and Human Services

Product Classification

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Device stimulator, nerve, transcutaneous, for pain relief
Regulation Description Transcutaneous electrical nerve stimulator for pain relief.
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeGZJ
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Neurostimulation Devices Branch (NSDB)
Submission Type 510(k)
Regulation Number 882.5890
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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