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U.S. Department of Health and Human Services

Product Classification

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Device device, discharge, electrostatic (for pain relief)
Definition An electrostatic discharge device which applies an electrostatic or coronal discharge to or near a person's skin for the symptomatic relief of pain.
Review Panel Physical Medicine
Product CodeNHH
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Physical Medicine and Neurotherapueutic Devices Branch (PNDB)
Unclassified Reason Pre-Amendment
Submission Type 510(k)
Device Class Unclassified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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