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U.S. Department of Health and Human Services

Product Classification

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Device device, iontophoresis, other uses
Regulation Description Iontophoresis device.
Regulation Medical Specialty Physical Medicine
Review Panel Physical Medicine
Product CodeEGJ
Premarket Review Neurological and Physical Medicine Devices (OHT5)
Neuromodulation and Rehabilitation Devices (DHT5B)
Submission Type 510(k)
Regulation Number 890.5525
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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