Fist Assist FA-1 Device Receives FDA Clearance for Increased Vein Circulation and Focal Arm Massage

June 22, 2021—Fist Assist Devices, LLC, announced that the company has received FDA 510(k) clearance of the Fist Assist FA-1 device and it has commenced marketing the technology in the United States.

According to the company, Fist Assist technology is indicated for use in the United States for intermittent, external wearable pneumatic compression for arm massage and increased vein circulation. In India, Canada, Europe, Australia, and New Zealand, the FA-1 device is marketed for increased forearm vein enhancement and arteriovenous fistula dilation/maturation.

“We are thrilled to receive FDA 510(k) clearance for the Fist Assist FA-1 device for focal arm massage and increased arm vein circulation,” commented Tej Singh MD, the company’s Founder and Chief Executive Officer. “This is a huge milestone for our company as we can now expand our commercialization efforts into the United States, a market we have been waiting to enter since our global launch in early 2020. This is a very exciting time for Fist Assist. We have been working for many years to bring the benefits of using the Fist Assist FA-1 device for arm massage and vein circulation to patients and consumers in the United States. Our goal at Fist Assist is to temporarily increase arm vein circulation in the treated areas and relieve minor muscle aches and pains.”