510(k) K053248

SMARTVEST AIRWAY CLEARANCE SYSTEM, MODEL TL by Electromed, Inc. — Product Code BYI

K053248 is an FDA 510(k) premarket notification submitted by Electromed, Inc. for the device "SMARTVEST AIRWAY CLEARANCE SYSTEM, MODEL TL". The FDA issued a decision of Substantially Equivalent on December 1, 2005. The device falls under product code BYI (Percussor, Powered-Electric), a Class II device regulated under 21 CFR 868.5665. Electromed, Inc. has at least 5 other 510(k) clearances on record.