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FDA Grants 510(k) Clearance to Sofwave’s Pure Impact for Strengthening and Firming of Arms

The U.S. Food and Drug Administration (FDA) has cleared Sofwave’s Pure Impact for strengthening and improving muscle tone, firmness, and sculpting of the arms.

The new nod complements Sofwave’s Superb’s claim to improve the appearance of skin laxity on the upper arm. Pure Impact is a plyometric muscle activation device, emulating a variety of complex and compound full-body muscle movements. Pure Impact Arms will be supported by the launch of the “Sofwave Endless Summer” marketing campaign.

Experts React

“It is readily evident that Pure Impact was developed by expert physiologists,” says New York City dermatologist Jessica Weiser, MD, in a news release. “My patients love the emulation of whole-body plyometric exercises as it not only emphasizes functional core strength and improved posture, but also yields a more sculpted physical appearance in patients through plyometric muscle activation. Pure Impact is unlike any previous muscle activation device; we proactively and preventatively integrate treatment into my patients’ wellness journeys. Sofwave plus Pure impact is the ideal treatment for GLP-1 patients to directly counter the risk of muscle loss from inactivity or aging (sarcopenia).“

 ICYMI: New York City dermatologist Doris Day, MD, discusses why she loves Sofwave. 

 

 

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