The FrequencerTM V2 is UL approved for North America, Europe, Australia and New Zealand.
The FDA found the device to be substantially equivalent to a legally marketed predicate device and thus permits the device to proceed to the US market.
Indications for Use:
The FrequencerTM provides airway clearance therapy and promotes bronchial drainage by inducing 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 designed for patients with respiratory ailments which include defective mucociliary clearance, as is typical in patients suffering from cystic fibrosis as well as chronic bronchitis, bronchiectasis, ciliary dyskinesia syndromes, asthma, 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 FrequencerTM is suitable for use in all environments (institution and homes).
- Frequencer licence number is 71410.
- Disposable adapters with filter licence number is 81958.
Health Canada is the federal regulator of therapeutic products, including medical devices.
The Medical Devices Bureau of the Therapeutic Products Directorate, Health Canada, is the Canadian federal regulator responsible for licensing medical devices in accordance with the Canadian Medical Devices Regulations.
The Bureau maintains a database of all licensed Class II, III, and IV medical devices offered for sale in Canada.
ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements.
Dymedso Inc. is ISO 13485-2003 certified since 2004. This certification is an indication of our commitment level to quality and servicing of medical devices.
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