# K103176: Frequencer

- Pathway: 510(k) (Traditional)
- Applicant: Dymedso, Inc.
- Decided: Jan 26, 2011 after 90 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
Longest line of descent: 6 generations back to K884098 (1988). 16 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100749: Frequencer Model V2X, Dymedso, Inc. (2010) Summary page 1.

## Most influential descendants
- K133057: Vibralung Acoustical Percussor (2014), 0 descendants of its own

## Indications for use
The Frequencerm V2x and Frequencerm V2 provide airway clearance therapy and promote bronchial drainage by inducing vibration in the chest walls. This device is intended to be a component of chest physiotherapy by providing a convenient method of external thorax manipulation. It is indicated for patients having respiratory ailments which involve defective mucociliary clearance, as is typical in patients suffering from cystic fibrosis as well as chronic bronchitis, bronchiectasis, ciliary dyskinesia syndromes, asthma, muscular dystrophy, neuromuscular degenerative disorders, postoperative atelectasis and thoracic wall defects. Indications for this form of therapy are described in the Clinical Practice Guidelines for Postural Drainage Therapy of the American Association for Respiratory Care (AARC) published fin 1991. This particular device provides a gentler, less painful form of therapy than the traditional "clapping" method of postural drainage therapy, allowing it to be used on patients who cannot be treated by clapping.

Source page: https://510kreport.com/device/K103176
Methodology: https://510kreport.com/methodology