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U.S. Department of Health and Human Services

Product Classification

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Device electrode, cutaneous
Regulation Description Cutaneous electrode.
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeGXY
Premarket Review Neurological and Physical Medicine Devices (OHT5)
Neuromodulation and Physical Medicine Devices (DHT5B)
Submission Type 510(k)
Regulation Number 882.1320
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Recognized Consensus Standards
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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