K-number	K240959
Device name	Respiratory Muscle Trainer
Applicant	Chongqing Moffy Innovation Technology Co., Ltd.
Product code	BYI
Device class	Class II
Decision date	Dec 18, 2024
Decision	Substantially Equivalent
Regulation	868.5665

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The Respiratory Muscle Trainer is a Positive Expiratory Pressure (PEP) device that vibrates airway walls and intermittently increases pressure during exhalation to help loosen and clear mucus secretions from airways. It is indicated for patients with chronic bronchitis, bronchiectasis, or other conditions requiring PEP therapy to maintain airway patency and reduce mucus buildup.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Substantial equivalence argument

Not stated in this summary.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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Respiratory Muscle Trainer

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