FREQUENCER - The FREQUENCER provides airway clearance therapy - Dymedso Inc

Duns Number:243498438

Device Description: The FREQUENCER provides airway clearance therapy and promotes bronchial drainage vibration 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.

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More Product Details

Catalog Number

DYMV2.3

Brand Name

FREQUENCER

Version/Model Number

V2.3

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

MR Safe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K103176

Product Code Details

Product Code

BYI

Product Code Name

Percussor, Powered-Electric

Device Record Status

Public Device Record Key

945fdb14-5de5-4928-bf10-32d16daa3a6e

Public Version Date

January 25, 2021

Public Version Number

3

DI Record Publish Date

December 19, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DYMEDSO INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 3