RhythmStar System (SL)

RhythmStar System (SL) is an FDA 510(k)-cleared medical device (K250793) manufactured by RhythMedix, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 20, 2026. Regulation: 8.