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U.S. Department of Health and Human Services

Product Classification
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Device oropharyngeal electrical stimulator
Definition An oropharyngeal electrical stimulator is a device that stimulates afferent nerve fibers of oropharyngeal mucosa. The device is intended to treat swallowing dysfunction. The device may incorporate a feeding tube.
Physical State Hardware with electronics generating electrical current and software monitoring treatment and storing patient data.
Technical Method Applies electrical current to stimulate sensory nerves in the oropharynx.
Target Area Oropharyngeal mucosa
Regulation Medical Specialty Ear Nose & Throat
Review Panel Ear Nose & Throat
Product CodeQQG
Premarket Review Division of Dental and ENT Devices (DHT1B)
Division of Dental and ENT Devices (DHT1B)
Submission Type 510(k)
Regulation Number 874.5950
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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