# K063645: Frequencer, Model 1001

- Pathway: 510(k) (Traditional)
- Applicant: Dymedso, Inc.
- Decided: Mar 15, 2007 after 98 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: 4 generations back to K884098 (1988). 14 ancestors in all.
3 later devices descend from it; 2 cite 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)
- K965192: Thairapy Vest System, American Biosystems, Inc. (1997) Summary page 1.
- K972859: Flutter D, Bradstreet Clinical Research Assoc., Inc. (1998) Summary page 1.
- K982889: Medpulse Respiratory Vest System, Model 1000, Electromed, Inc. (1999) Summary page 1.
- K012928: Abi Vest Airway Clearance System, Advanced Respiratory (2001) Summary page 1.
- K031876: Electro Flo Percussor, Model 5000, Med Systems (2003) Summary page 1.

## Most influential descendants
- K100749: Frequencer Model V2X (2010), 2 descendants of its own
- K103176: Frequencer (2011), 1 descendant of its own
- K133057: Vibralung Acoustical Percussor (2014), 0 descendants of its own

## Indications for use
The FrequencerTM provides airway clearance therapy and promotes bronchial drainage by inducing vibration in the chest walls. This device is intended to be a component of postural drainage therapy 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, post-operative 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 in 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/K063645
Methodology: https://510kreport.com/methodology