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U.S. Department of Health and Human Services

Product Classification

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Device magnetotherapy device for pain relief
Regulation Description Transcutaneous electrical nerve stimulator for pain relief.
Definition Simptomatic relief of chronic intractable, post-traumatic and post-surgical pain.
Physical State electronic device (generator) with electromagnetic coils, which can be attached to the body as patches or brought to the eproximity of the treated area.
Technical Method inducing electrical current in the tissues by means of passing alternatng electrical current through the electromagnetic coil(s).
Target Area below neck
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeORS
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
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible