# K240959: Respiratory Muscle Trainer

- Pathway: 510(k) (Traditional)
- Applicant: Chongqing Moffy Innovation Technology Co., Ltd.
- Decided: Dec 18, 2024 after 254 days
- Product code: BYI (Percussor, Powered-Electric)
- Device class: 2
- Regulation: 21 CFR 868.5665
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for 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 bronchitis or bronchiectasis and in conjunction with a medical need for positive expiratory pressure (PEP) therapy.

Source page: https://510kreport.com/device/K240959
Methodology: https://510kreport.com/methodology