FREQUENCER
DYMEDSO INC.
DYMEDSO INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3004365906 | 3004365906 | DYMEDSO INC. | 1 | N | 2020-04-25 | 2120, 32nd Avenue Montreal Quebec CA H8T 3H7 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 22470 | 1541053021 | K103176 | FREQUENCER | BYI | 2011-01-26 |
| 22470 | 1130087731 | K100749 | FREQUENCER MODEL V2X | BYI | 2010-08-31 |
| 22470 | 1279657996 | K063645 | FREQUENCER, MODEL 1001 | BYI | 2007-03-15 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| BYI | 3 | 2011-01-26 |
PMN#
GUDID#
FREQUENCER - "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."
2017-01-25
FREQUENCER - "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."
2017-02-17
FREQUENCER - "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."
2016-12-19