Distributors
Certifications
In Canada, the DizzyFIX device for treatment of BPPV is a Class I medical device according to Rule 7( 1) of the Medical Devices Regulations and has been reviewed and determined to be such by the Device Licensing section of the Medical Devices Bureau of Health Canada.
The DizzyFIX also complies with Canada's Medical Devices Regulations, which include:
- Safety and effectiveness (Sections 10 to 20)
- Labelling (Sections 21 to 23)
- Distribution records (Sections 52 to 58)
- Mandatory problem reporting (Sections 59 to 62)
- Recall requirements (Sections 63 to 65)
Medical Device Establishment Licence 2682
It also complies with the requirements of Sections 3 and 19 to 21 of Canada's Food and Drugs Act.
CLEARWATER has made application for an Establishment Licence from Canada's Health Products and Food Branch (HPFB) Inspectorate.
DizzyFIX is CE registered in the EU.
Clearwater Holdings EU limited (authorized representative)
Clearwater Holdings EU limited (authorized representative)
In the U.S.A., a prescription only version of the DizzyFIX is FDA cleared and readily available upon request. A non-prescription version of the product is available for purchase directly through this website.