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U.S. Department of Health and Human Services

Product Classification
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Device transcutaneous electrical nerve stimulator for the relief of congestion
Definition A transcutaneous electrical nerve stimulator for the relief of congestion is a device that electrically stimulates the skin overlying the paranasal sinuses to relieve congestion.
Physical State This device is for external application and includes an active and return electrode, battery, and software.
Technical Method This device is an electrical stimulator and applies a low level of electrical current to the skin overlying the paranasal sinuses.
Target Area The skin overlying the paranasal sinuses
Regulation Medical Specialty Ear Nose & Throat
Review Panel Ear Nose & Throat
Product CodeQNU
Premarket Review Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Dental and ENT Devices (DHT1B)
Submission Type 510(k)
Regulation Number 874.6000
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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