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510(k) Data Aggregation
K Number
K241338Device Name
Peak Flow Meter
Manufacturer
Chongqing Moffy Innovation Technology Co.,Ltd.
Date Cleared
2024-12-31
(232 days)
Product Code
BZH
Regulation Number
868.1860Why did this record match?
Applicant Name (Manufacturer) :
Chongqing Moffy Innovation Technology Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SMPF-1A, SMPF-1B, SMPF-2A, SMPF-2B, SMPF-3A, SMPF-3B: This device is intended to monitor a patient's Peak Expiratory Flow (PEF) at home. The device is designed for adults and children over 5 years of age with caregiver supervision. The device is intended for monitoring respiratory onditions such as asthma. The device is for Over-The-Counter Use. SMPF-1C, SMPF-1D, SMPF-2C, SMPF-2D, SMPF-3C, SMPF-3D: This device is intended to monitor a patient's Peak Expiratory Flow (PEF) and Forced Expiratory Volume (FEVI) in one second at home. The device is designed for adults and children over 5 years of age with caregiver supervision. The device is intended for monitoring respiratory conditions such as asthma. The device is for Over-The-Counter Use.
Device Description
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K Number
K240959Device Name
Respiratory Muscle Trainer
Manufacturer
Chongqing Moffy Innovation Technology Co.,Ltd.
Date Cleared
2024-12-18
(254 days)
Product Code
BYI
Regulation Number
868.5665Why did this record match?
Applicant Name (Manufacturer) :
Chongqing Moffy Innovation Technology Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Respiratory Muscle Trainer is indicated for use as a Positive Expiratory Pressure (PEP) Device for improving the clearance of mucus secretions from the airways. Respiratory Muscle Trainer vibrates the airway walls to assist in loosening mucus and intermittently increases endobronchial pressure so that the airway patency can be maintained during exhalation, reducing the potential of mucus becoming trapped as it moves up the airways.
The device may also be useful in the removal of mucus from patients who have chronic bronchiectasis and in conjunction with a medical need for positive expiratory pressure (PEP) therapy.
Device Description
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