Sofwave Gains FDA Clearance for Pure Impact? Device to Firm and Strengthen Arms in the U.S.
13 August 2024
Sofwave Medical, a leader in non-invasive aesthetic medical devices, has received 510(k) premarket notification clearance from the U.S. Food and Drug Administration (FDA) to extend the use of its Pure Impact™ device.
This expansion allows the device to target muscle tone and firmness in the arms.
The Pure Impact™ device, known for its plyometric muscle activation technology, now includes the ability to simulate high-intensity interval training exercises, such as burpees and star jumps, specifically for the arms.
This advancement enhances the potential for full-body muscle activation using Sofwave's PlyoPulse™ electric muscle stimulation technology, aiming to improve muscle tone and reduce arm laxity as individuals age or lose weight.
The new application of Pure Impact™ is designed to support wellness routines and counteract muscle loss associated with inactivity or aging.
The “Sofwave Endless Summer” marketing campaign will promote the benefits of the expanded use, highlighting improvements in both dermal laxity and muscle tone, and positioning the combination of Sofwave and Pure Impact™ as an effective treatment for enhancing physical appearance and strength.
Source: globenewswire.com