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U.S. Department of Health and Human Services

Product Classification
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Device intra-pulmonary percussive vibration (ipv) devices
Regulation Description Powered percussor.
Definition It is intended to mobilize mucus using vibration and/or pressure delivered through a mouthpiece into the airways.
Physical State A control unit with a breathing circuit and mouthpiece/facemask.
Technical Method The patient breathes into the mouthpiece while the control unit provides vibration and/or percussive (oscillatory) airflow. This loosens the mucus from the airways so it can be coughed up or suctioned.
Target Area Upper airways including the trachea and bronchial tree.
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeSDT
Premarket Review Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Submission Type 510(k)
Regulation Number 868.5665
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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