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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 Neurological and Physical Medicine Devices (OHT5)
Neuromodulation and Physical Medicine Devices (DHT5B)
Submission Type 510(k)
Regulation Number 882.5890
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible