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U.S. Department of Health and Human Services

Product Classification

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Device device, aversive conditioning
Regulation Description Aversive conditioning device.
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeHCB
Premarket Review Neurological and Physical Medicine Devices (OHT5)
Neuromodulation and Physical Medicine Devices (DHT5B)
Submission Type 510(k)
Regulation Number 882.5235
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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