Fist Assist Devices has received US Food and Drug Administration (FDA) 510(k) clearance for use of the Fist Assist FA-1 device in the USA as an arm massage and increased vein circulation device, and has commenced marketing the Fist Assist FA-1 device for this use indication.
“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,” said Fist Assist CEO and founder Tej Singh. “This is a huge milestone for our company as we can now expand our commercialisation efforts into the USA—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 USA. Our goal at Fist Assist is to temporarily increase arm vein circulation in the treated areas, and relieve minor muscle aches and pains.”
Fist Assist is based in Silicon Valley, USA and has developed its Fist Assist technology over the course of the past 30 years. This technology is patent protected and is focused on developing an intermittent, external wearable pneumatic compression for arm massage and increased vein circulation in the USA—as well as increased forearm vein enhancement and arteriovenous (AV) fistula dilation/maturation in India, Canada, Europe, Australia, and New Zealand.