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Frequencer

FDA UDI

Class II (US FDA UDI)

by Dymedso, Inc.

Identity

Trade Name
FREQUENCER FDA UDI
Generic Name
Chest-percussion airway secretion-clearing system FDA UDI
Device Name
The FREQUENCER provides airway clearance therapy and promotes bronchial drainage vibration in chest walls. The device is intended to be a component of chest physiotherapy by providing a convenient method of external thorax manipulation. It is intended for patients having respiratory ailments which involve defective mucocillary clearance, as is typical in patients suffering from cystic fibrosis as well as chronic bronchiti, bronchiectasis, cillary dyskinesia syndromes, asthma, muscular dystrophy, neuromuscular degenerative disorders, post-operative atelectasis and thoracic wall defects. Indications for this form of therapy are described in 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 from the traditional "clapping" method of postural drainage therapy, allowing it to be used on patients who cannot be treated by clapping. The Frequencer is suitable for use in all patient-care environments including home health-care. FDA UDI
Model / Reference
V2.3 FDA UDI
Description
The FREQUENCER provides airway clearance therapy and promotes bronchial drainage vibration in chest walls. The device is intended to be a component of chest physiotherapy by providing a convenient method of external thorax manipulation. It is intended for patients having respiratory ailments which involve defective mucocillary clearance, as is typical in patients suffering from cystic fibrosis as well as chronic bronchiti, bronchiectasis, cillary dyskinesia syndromes, asthma, muscular dystrophy, neuromuscular degenerative disorders, post-operative atelectasis and thoracic wall defects. Indications for this form of therapy are described in 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 from the traditional "clapping" method of postural drainage therapy, allowing it to be used on patients who cannot be treated by clapping. The Frequencer is suitable for use in all patient-care environments including home health-care. FDA UDI

Identifiers

Catalog Number
DYMV2.3 FDA UDI
Primary DI / UDI-DI
B401DYMV230 FDA UDI
510(k) Number
K103176 FDA UDI
FDA Product Code
BYI FDA UDI
GMDN Term
Chest-percussion airway secretion-clearing system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5665 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Chest-percussion airway secretion-clearing system

Frequencer by Dymedso, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Chest-percussion airway secretion-clearing system.

Cleared under the same submission

K103176 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dymedso, Inc.

Sources (1)

  • FDA UDI 454a5227-233f-4edf-999d-07627762c048 35 fields · synced Jun 8, 2026