Sofwave Medical, an aesthetic medical devices developer, has received marketing clearance from Health Canada for its Pure Impact strength and muscle toning device.
Pure Impact is a plyometric muscle toning and firming system. It is engineered to trigger multiple muscle groups and body areas simultaneously in one session.
It will be commercialised in Canada by using PlyoPulse Electric Muscle Stimulation (EMS) technology.
The device along with the technology secured the US Food and Drug Administration (FDA) 510(k) clearance in January.
Sofwave Medical’s PlyoPulse technology uses the effectiveness of plyometric exercises in a streamlined 30-minute treatment.
The technology doesn’t need electrode rearrangement because of easy digital programming. It also has zero treatment delays to enhance patient turnover and expedited ROI.
The medical devices developer said that the modular add-on redefines toning with up to 16 synchronised electrodes that emulate plyometric exercises.
Furthermore, the device is said to deliver rapid results to patients requiring muscle strengthening and toning across multiple muscle groups without needing gels, liquids, or belts.
The strength and muscle toning device is currently approved and available in the US. It was designed as a modular add-on component for the Synchronous Ultrasound Parallel Beam (SUPERB) system.
The SUPERB technology has received the FDA clearance for enhancing facial lines and wrinkles, as well as lifting the eyebrow, submental tissue, and neck tissue.
Additionally, it offers short-term improvement in cellulite’s appearance, offering physicians smart, simple, effective, and safe aesthetic solutions for patients.
As a modular Sofwave platform product, Pure Impact treatment can be used alongside the SUPERB system or as a standalone option.
Sofwave Medical CEO Louis Scafuri said: “The latest regulatory approval from Health Canada allows the company to immediately initiate Sofwave’s second Pure Impact launch in North America.
“Pure Impact with PlyoPulse technology is the result of years of research and development and was developed in response to consumers’ growing demand for a cost-effective, non-invasive muscle toning treatment alternative to conventional plastic surgery.
“The US Pure Impact product launch has been a major milestone this year for Sofwave, and we continue to seek additional approvals in other key markets for this highly innovative product.”
