Where does Dyna-Pulse stand with the FDA?
The FDA doesn’t “certify” or “approve” medical devices, it only does this for pharmaceuticals. The FDA has a registration process for medical devices but has yet to create a category for the advanced technology used by Dyna-Pulse. Austin Medical Research has approached the FDA and is working to have a new category added that will include devices like the Dyna-Pulse. The Dyna-Pulse emissions are less than minimum emissions standards of both FDA and the World Health Organization and are fully covered by product liability insurance.
