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U.S. Department of Health and Human Services

Product Classification

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Device neuromuscular tongue stimulator to treat motor deficits
Definition An electrical tongue nerve stimulator to treat motor deficits is a prescription device that consists of a non-implantable apparatus to generate electrical pulses for stimulation of the nerves in the tongue to provide treatment of motor deficits.
Physical State Software
Technical Method Patient uses software on computer.
Target Area Brain
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeQCF
Premarket Review Neuromodulation and Rehabilitation Devices (DHT5B)
Neuromodulation and Rehabilitation Devices (DHT5B)
Submission Type 510(k)
Regulation Number 882.5889
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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