Fist Assist Devices, LLC Announces 510(k) Clearance for Focal Arm Massage and Increased Vein Circulation

Fist Assist Devices, LLC, has received FDA 510(k) clearance for use of the Fist Assist FA-1 device in the United States as an arm massage and increased vein circulation device and has commenced marketing the Fist Assist FA-1 device for that indication for use.

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Business Wire, Inc.Business Wire, Inc.
Retrieved on: 
Tuesday, June 22, 2021
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Tags: 
FDA, Medical devices, Health, Physical therapy, Cardiology, Medicine, Manual therapy, Massage, Fist, Food and Drug Administration, Health care, Health, Medical devices, Prosthetics
Geotags: 
California, United States, NEW ZEALAND, EUROPE, INDIA, AUSTRALIA, SILICON VALLEY, CANADA
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Summary
Key Points: 
  • Fist Assist Devices, LLC, has received FDA 510(k) clearance for use of the Fist Assist FA-1 device in the United States as an arm massage and increased vein circulation device and has commenced marketing the Fist Assist FA-1 device for that indication for use.
  • 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.
  • 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 Devices is a privately held company from Silicon Valley, CA that has developed the Fist Assist technology over the past 30 years.


Fist Assist Devices, LLC, has received FDA 510(k) clearance for use of the Fist Assist FA-1 device in the United States as an arm massage and increased vein circulation device and has commenced marketing the Fist Assist FA-1 device for that indication for use.

“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. 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,” said Tej Singh MD, MBA, Chief Executive Officer and Founder of Fist Assist Devices, LLC. “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.”

About Fist Assist Devices, LLC

Fist Assist Devices is a privately held company from Silicon Valley, CA that has developed the Fist Assist technology over the past 30 years. The Fist Assist technology is patent protected and is focused on developing an intermittent, external wearable pneumatic compression for arm massage and increased vein circulation in the United States and increased forearm vein enhancement and AV fistula dilation/maturation in India, Canada, Europe, Australia, and New Zealand.

For further information, connect to www.fistassistdevices.com

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