HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch)

HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch) is an FDA 510(k)-cleared medical device (K213655) manufactured by Hilltek, LLC. This device is classified under the Physical Medicine specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 16, 2023. Regulation: 8.