510(k) K253148

RX-1 Sleep by Vivaquant, Inc. Dba Rhythm Express — Product Code MNR

K253148 is an FDA 510(k) premarket notification submitted by Vivaquant, Inc. Dba Rhythm Express for the device "RX-1 Sleep". The FDA issued a decision of Substantially Equivalent on June 22, 2026. The device falls under product code MNR (Ventilatory Effort Recorder), a Class II device regulated under 21 CFR 868.2375.