510(k) K250259

TeleRehab Aermos Cardiopulmonary Rehabilitation by The ScottCare Corporation — Product Code DRG

K250259 is an FDA 510(k) premarket notification submitted by The ScottCare Corporation for the device "TeleRehab Aermos Cardiopulmonary Rehabilitation". The FDA issued a decision of Substantially Equivalent on June 4, 2025. The device falls under product code DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency), a Class II device regulated under 21 CFR 870.2910. The ScottCare Corporation has at least 4 other 510(k) clearances on record.