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U.S. Department of Health and Human Services

Product Classification

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Device mechanical ventilator
Regulation Description Continuous ventilator.
Definition This device is a volume assist ventilator intended to aid adult patients with respiratory insufficiency. It is designed for patients who are capable of spontaneously breathing a minimum tidal volume of 3.5cc/kg of predicted body weight. The device is designed for continuous applications such as patient ambulation, physical therapy, occupational therapy, respiratory therapy, and other rehabilitation efforts in an institutional or home care environment. The device is intended for operation by trained personnel, patients or caregiver under the direction of a physician,
Physical State A small, wearable ventilator that interfaces with proprietary nasal and tracheostomy patient interfaces.
Technical Method The device consists of two components: a ventilator and a patient interface. The device is a light-weight, portable, electronically timed and controlled volume assist ventilator. The device delivers 100% oxygen in volumes of 50-250ml. The device delivers augmented volumes of 100% oxygen that are blended in the interface, patient's airway and lung with ambient air provided by the patient's spontaneous breath.
Target Area The device delivers augmented volumes of 100% oxygen into the patient's airway.
Regulation Medical Specialty Anesthesiology
Review Panel Anesthesiology
Product CodeONZ
Premarket Review Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices (DHT1C)
Submission Type 510(k)
Regulation Number 868.5895
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible