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U.S. Department of Health and Human Services

Product Classification
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Device external mechanical stimulator for the relief of congestion
Definition The external mechanical stimulator for the relief of congestion delivers vibrations to the sinus and nasal areas to relieve congestion.
Physical State The external mechanical stimulator consists of a transducer that delivers vibrations.
Technical Method The external mechanical stimulator delivers resonant vibration through transducers
Target Area Sinus and nasal areas of the face.
Regulation Medical Specialty Ear Nose & Throat
Review Panel Ear Nose & Throat
Product CodeQZC
Premarket Review Division of Dental and ENT Devices (DHT1B)
Division of Dental and ENT Devices (DHT1B)
Submission Type 510(k)
Regulation Number 874.6010
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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