What is FDA 510(K) Cleared Devices?
These medical devices are ones that FDA has determined to be substantially equivalent to legally marketed device.
A premarket notification, referred to as a 510(k), must be submitted to FDA for clearance.
– be suitable for their intended use
– be adequately packaged and properly labeled
– have establishment registration and device listing forms on file with FDA
– be manufactured under a quality system
To deliver the safest, highest quality products to our customers,
Air Relax took the extra step to become FDA 510(k) cleared device.
That means all aspects of our manufacturing and testing are accepted and backed by the FDA guidelines.
Benefits of Air Relax Blood & Lymphatic Circulation Therapy System:
– Helps relieve knee problems, swelling leg, tension, varicose veins, water retention, and cramps
– Improves blood & lymphatic system circulation, which nourishes cells and improves waste elimination
– Releases of nerve compression
– Flush waste naturally
– Venous Insufficiency
– Athletic Sports Recovery
– Releases endorphins/amino acids that work as the body’s natural painkiller
– Perfect after a workout. Air Relax is a great choice for professional athletes
– No side effects
– Helps early stages of cellulite
Enjoy, Stay Fit And Healthy!
– Rate Voltage: AC 110-120V, 60Hz [United States, Canada, Various cities in Brazil, Mexico, and most of America continent countries]
– Power Consumption: 30W
– Device Size : 10.2(W) x7.0(H)x 5.1(D)-Inch
– Cuff Size: [Opening: 27-Inch] [Mid Thigh: 24-Inch] [Knee: 20-Inch] [Calf: 18-Inch] [Ankle: 16-Inch] [Arch(Instep): 13-Inch]. See extension cuffs to increase circumference
– Air Compression Pump: 15 liters per minute
– Contents: Air Relax Device, right & left leg cuff, and U.S. Manual
*Note: 1 Year Worry-Free Warranty.