FDA clears Pure Impact device for strengthening, sculpting arm laxity

Key takeaways:

• Pure Impact Arms expands Pure Impact’s indication to include strengthening and improving muscle tone and firmness of arms.
• The product will be launched with the company’s Sofwave Endless Summer campaign.

The FDA has cleared Pure Impact for its expanded use in strengthening and improving muscle tone and firmness sculpting of the arms, Sofwave Medical Ltd announced in a press release.

“Pure Impact remains the world’s first plyometric muscle activation device, emulating a variety of complex and compound full-body muscle movements,” Louis Scafuri, CEO of Sofwave Medical, said in the release. “The inclusion of Pure Impact plyometrics for the arms enables the emulation of complex upper body cardio-muscular high-intensity interval training workouts, such as burpees and star jumps. Importantly, we believe that Sofwave plus Pure Impact provides an enhancement of physical appearance in conjunction with diet and exercise regimens. As patients age or lose weight, Pure Impact Arms contributes to increased tone, and decreased overall arm laxity.”

Following the FDA’s 510k premarket notification clearance for Pure Impact Arms, the product will be supported by the launch of the company’s Sofwave Endless Summer marketing campaign.

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