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 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 intended for patients having respiratory ailments which involve defective mucocillary clearance, as is typical in patients suffering from cystic fibrosis as well as chronic bronchitis, bronchiectasis, cillary dyskinesia syndromes, asthsma, 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 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.
Catalog Number
DYMV2X
Brand Name
FREQUENCER
Version/Model Number
V2X
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
BYI
Product Code Name
Percussor, Powered-Electric
Public Device Record Key
99ba5fa3-63e8-432a-8ede-f5691cd40b2d
Public Version Date
January 25, 2021
Public Version Number
3
DI Record Publish Date
February 17, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 3 |