FREQUENCER

Primary DI
B402DYMV23
Brand
FREQUENCER
Company
Dymedso Inc
Model
V2.3
Catalog number
DYMV2.3
Device 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."
Published
2016-12-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
OTC
true

Product Codes#

Code, Name table
CodeName
BYIPercussor, Powered-Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYIPercussor, Powered-ElectricAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103176000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103176000FREQUENCERDymedso, Inc.2011-01-26BYI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B402DYMV23PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Chest-percussion airway secretion-clearing systemAn assembly of devices designed to provide external mechanical percussion (rapid tapping) to the chest wall of a patient (child to adult) to loosen excessive airway secretions [mucus or sputum (phlegm)] to promote airway clearance and improve bronchial drainage for patients with respiratory disease [e.g., cystic fibrosis (CF), neuromuscular disease, bronchitis, bronchiectasis, chronic obstructive pulmonary disease (COPD)]. It consists of a mains electricity (AC-powered) applicator with connecting cable and a control unit. The device is portable and operated by a healthcare professional in a medical facility or in the home.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
243498438
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B401DYMV230FREQUENCERV2.3DYMV2.32017-01-25
B401DYMV2X0FREQUENCERV2XDYMV2X2017-02-17

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