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U.S. Department of Health and Human Services

Product Classification
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Device brain stimulation programming planning software.
Regulation Description Brain stimulation programming planning software.
Definition The brain stimulation programming planning software is a prescription device intended to assist in planning stimulation programming for implanted brain stimulators.
Physical State Software
Technical Method Software to display modeled stimulation field in the brain.
Target Area Brain
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeQQC
Premarket Review Office of Neurological and Physical Medicine Devices (OHT5)
Neuromodulation and Rehabilitation Devices (DHT5B)
Submission Type 510(k)
Regulation Number 882.5855
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 Not Third Party Eligible
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