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U.S. Department of Health and Human Services

Product Classification

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Device electrode, needle, diagnostic electromyograph
Regulation Description Diagnostic electromyograph needle electrode.
Regulation Medical Specialty Physical Medicine
Review Panel Neurology
Product CodeIKT
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Physical Medicine and Neurotherapueutic Devices Branch (PNDB)
Submission Type 510(k)
Regulation Number 890.1385
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review
Accredited Persons

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