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U.S. Department of Health and Human Services

Product Classification

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Device stimulator, nerve, electrical, transcutaneous, with limited output, for pain relief
Regulation Description Transcutaneous electrical nerve stimulator for pain relief.
Definition Nerve stimulation for relief of pain.
Physical State Electrical stimulation unit with leads and cutaneous electrodes
Technical Method Stimulation of nerves using electrical current applied to electrodes on a patient's skin
Target Area Electrodes are placed on the skin in proximity to the painful area
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeNYW
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Neurostimulation Devices Psychiatry Branch (NSDP)
Submission Type 510(k)
Regulation Number 882.5890
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible