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U.S. Department of Health and Human Services

Product Classification

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Device stimulator, electrical, transcutaneous, with limited output, for aesthetic purposes
Regulation Description Transcutaneous electrical nerve stimulator for pain relief.
Definition Electrical stimulation for aesthetic purposes
Physical State Electrical stimulation unit with leads and cutaneous electrodes
Technical Method Electrical stimulation using current applied to electrodes on a patient's skin
Target Area Electrodes are placed on the skin in proximity to the area of interest
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeNYX
Premarket Review Neuromodulation and Physical Medicine Devices (DHT5B)
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
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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