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510(k) Data Aggregation

    K Number
    K222496
    Device Name
    Electromed SmartVest Airway Clearance System
    Manufacturer
    Electromed, Inc.
    Date Cleared
    2022-11-18

    (92 days)

    Product Code
    BYI
    Regulation Number
    868.5665
    Why did this record match?
    Applicant Name (Manufacturer) :

    Electromed, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SmartVest® Airway Clearance System, Model Clearway is designed to deliver high frequency chest wall oscillation to promote airway clearance and improve bronchial drainage. The SmartVest® System is indicated when external chest manipulation is the physician's treatment of choice to enhance mucus transport.
    Device Description
    The modified Electromed SmartVest® Airway Clearance System, Model Clearway is an electrically powered percussor device designed to deliver high frequency chest wall oscillation (HFCWO) to aid in freeing mucus deposits in the lungs to improve bronchial drainage and airway clearance under the order of a physician's prescription. The primary components of both the proposed modified and predicate HFCWO Airway Clearance Systems consist of an Air Pulse Generator, an Inflatable Vest, and an Air Hose that connects the Generator to the Inflatable Vest. The Air Pulse Generator produces small volumes of pressurized air pulses that are rapidly delivered to the Inflatable Vest via the Air Hose at a selected oscillatory frequency between 5-20 times per minute (Hz). The Inflatable Vest imparts the oscillatory air pulses to the patient's external chest wall. These pressurized air pulses promote transient increases in airflow within the lungs that loosens mucus sufficiently to facilitate expulsion by the patient when normal respiratory function is not capable.
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    K Number
    K132794
    Device Name
    SMARTVEST AIRWAY CLEARANCE SYSTEM
    Manufacturer
    ELECTROMED, INC.
    Date Cleared
    2013-12-19

    (104 days)

    Product Code
    BYI
    Regulation Number
    868.5665
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELECTROMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SmartVest® Airway Clearance System, Model SQL is designed to deliver high frequency chest wall oscillation to promote airway clearance and improve bronchial drainage. The SmartVest System is indicated when external chest manipulation is the physician's treatment of choice to enhance mucus transport.
    Device Description
    The modified Electromed SmartVest® Airway Clearance System, Model SQL is an electrically powered percussor device designed to deliver high frequency chest wall oscillation (HFCWO) to aid in freeing mucus deposits in the lungs in order to improve bronchial drainage under the order of a physician's prescription. The primary components of both the proposed modified and predicate HFCWO Airway Clearance Systems consist of an Air Pulse Generator, an Inflatable Vest, and an Air Hose that connects the Generator to the Inflatable Vest. The Air Pulse Generator produces small volumes of pressurized air pulses that are rapidly delivered to the Inflatable Vest via the Air Hose at a selected oscillatory frequency between 5-20 times per minute (Hz). The Inflatable Vest imparts the oscillatory air pulses as pressure forces to the patient's external chest wall. These pressurized air pulses promote transient increases in airflow within the lungs that loosens mucus sufficiently to facilitate expulsion by the patient when normal respiratory function is not capable.
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    K Number
    K053248
    Device Name
    SMARTVEST AIRWAY CLEARANCE SYSTEM, MODEL TL
    Manufacturer
    ELECTROMED, INC.
    Date Cleared
    2005-12-01

    (10 days)

    Product Code
    BYI
    Regulation Number
    868.5665
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELECTROMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Electromed SmartVest® Airway Clearance System, Model TL is designed to deliver high-frequency chest wall oscillation to promote airway clearance and improve bronchial drainage. The SmartVest® System is indicated when external chest manipulation is the physician's treatment of choice to enhance mucus transport.
    Device Description
    The proposed SmartVest® Airway Clearance System, Model TL is designed to deliver high-frequency chest wall oscillation to promote airway clearance and improve bronchial drainage. The SmartVest® System is indicated when external chest manipulation is the physician's treatment of choice to enhance mucus transport. The primary components of the SmartVest® System include an Air-Pulse Generator, an Inflatable Vest and Vest/Generator Connector Hose. The Air-Pulse Generator produces oscillating pressurized air-pulses that are delivered to the Inflatable Vest by the Vest/Generator Hose. The air-pulses produced by the Generator cause the Vest to rapidly inflate and deflate against the external chest wall of a patient to promote airway clearance by creating high-frequency chest wall oscillation (HFCWO) resulting in mobilization of bronchial secretions.
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    K Number
    K040367
    Device Name
    MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 2000EZ
    Manufacturer
    ELECTROMED, INC.
    Date Cleared
    2004-04-07

    (54 days)

    Product Code
    BYI
    Regulation Number
    868.5665
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELECTROMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Electromed MedPulse® Respiratory Vest System Model 2000ez is designed to deliver high-frequency chest wall oscillation to promote airway clearance and improve bronchial drainage. The MedPulse® System is indicated when external chest manipulation is the physician's treatment of choice to enhance mucus transport.
    Device Description
    The proposed MedPulse® Respiratory Vest System Model 2000ez is designed to deliver high-frequency chest wall oscillation to promote airway clearance and improve bronchial drainage. The MedPulse® System is indicated when external chest manipulation is the physician's treatment of choice to enhance mucus transport. The primary components of the MedPulse® System include an Air-Pulse Generator, an Inflatable Vest and Vest/Generator Connector Hose. The Air-Pulse Generator produces oscillating pressurized air-pulses that are delivered to the Inflatable Vest by the Vest/Generator Hose. The air-pulses produced by the Generator cause the Vest to rapidly inflate and deflate against the external chest wall of a patient to promote airway clearance by creating high-frequency chest wall oscillation (HFCWO) resulting in mobilization of bronchial secretions.
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    K Number
    K982889
    Device Name
    MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 1000
    Manufacturer
    ELECTROMED, INC.
    Date Cleared
    1999-06-01

    (288 days)

    Product Code
    BYI
    Regulation Number
    868.5665
    Why did this record match?
    Applicant Name (Manufacturer) :

    ELECTROMED, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Electromed Medpulse™ RespiratoryVest System is designed specifically to deliver I its Lievency chest wall oscillation to promote airway clearance and improve bronchial drainage. The Medpulse™ Respiratory Vest System is indicated when external chest manipulation is the physician's treatment of choice to enhance mucus transport.
    Device Description
    The Medpulse™ Respiratory Vest System is a high frequency chest wall oscillation device designed to aid in bronchial mucus clearance. The system consists of an air-pulse generator, an inflatable vest and air connection tubing. Alternating positive pressure air pulses are delivered to the inflatable vest via the air-pulse generator. Rapidly alternating positive pressure air pulses result in the inflation and deflation of the vest which frequency chest wall oscillation to the patient and thus enhances clearance of mucus from the lungs. The frequency of the air-pulses, time settings and amount of pressure are operator controlled according to physician's prescription.
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