483
Electromed, Inc.Electromed, Inc. – FDA 483, Jan 13, 2023
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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ID · 19f827b6-7dac-4558-b764-3930fa8df658
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