Speed Hound ProPerformance Recovery System Awarded FDA 510(k) Clearance
Menlo Brands, LLC announces that the U.S. Food & Drug Administration has provided clearance of its ProPerformance Recovery System as a medical device marketed under the Speed Hound brand. The Center for Devices and Radiological Health (CDRH) has designed this as a Class II Medical Device and evaluated under regulation 21 CFR 890.5650. The testing and evaluation included, but not limited to, bench testing of all software, controls, indicators, safety and performance. The device also complies with the latest IEC standards on electromagnetics.
This clearance validates the use of the device for the relief of muscle aches and pains and for increase in circulation in the treated areas. This system works by using dynamic pressure to inflate and deflate the sleeve balloons to simulate kneading and stroking of the limbs and tissues in order to promote blood circulation and lymph flow. Use settings approved for marketing and distribution are hospitals, rehabilitation clinics, hospitals, in addition to home use.
The ProPerformance Recovery System provides a wide range of adjustable pressure ranging from 20mmHg to 200 mmHg, the ability to turn individual compression zones on or off, and two different massage modes (therapeutic mode to reduce muscle soreness and flush mode to reduce swelling).
“We are extremely excited about this. Pressure is a very individualized thing and our system allows the user to customize their recovery with a wide range of pressures and zone toggles. This presents a significant advantage compared to existing systems.” said Sam Chi, MSPT, CEO of Menlo Brands, LLC.
