Navigator (FMNVG15); Navigator XL (FMNVX06)

Navigator (FMNVG15); Navigator XL (FMNVX06) is an FDA 510(k)-cleared medical device (K240105) manufactured by Forcemech International, 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 August 28, 2024. Regulation: 8.