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510(k) Data Aggregation
K Number
K222018Device Name
Breathe+
Manufacturer
PEEP Medical LLC dba GO2 Devices
Date Cleared
2023-06-02
(329 days)
Product Code
BWF
Regulation Number
868.5690Why did this record match?
Applicant Name (Manufacturer) :
PEEP Medical LLC dba GO2 Devices
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Breathe+ is intended for use as a Positive Expiratory Pressure Device to help prevent or reverse atelectasis in adult patients needing PEP therapy. Intended for single-patient, multi-use in a hospital or home care setting.
Device Description
The subject device provides PEP only. The subject device is an oral device that provides positive expiratory airway pressures to enhance expiratory muscle strength while preventing and reversing atelectasis. Furthermore, the device is hands-free.
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