510(k) K252849

AffloVest® Mobile Airway Clearance Therapy by Tactile Medical — Product Code BYI

K252849 is an FDA 510(k) premarket notification submitted by Tactile Medical for the device "AffloVest® Mobile Airway Clearance Therapy". The FDA issued a decision of Substantially Equivalent on April 30, 2026. The device falls under product code BYI (Percussor, Powered-Electric), a Class II device regulated under 21 CFR 868.5665. Tactile Medical has at least 1 other 510(k) clearance on record.