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U.S. Department of Health and Human Services

Product Classification

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Device stimulator, electrical, transcutaneous, with limted 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 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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