FDA 483 - Electromed, Inc. - January 13, 2023

Electromed, Inc. of New Prague, MN, was inspected from January 9-13, 2023, and received one observation. The firm failed to submit a Medical Device Report (MDR) within 30 days for a SmartVest Airway Clearance System component that malfunctioned by overheating and powering off, which could cause serious injury.