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