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

Source: https://www.keypedia.com/records/483/electromed-inc/19f827b6-7dac-4558-b764-3930fa8df658

> FDA 483 for Electromed, Inc. on January 13, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Electromed, Inc.
- Inspection Date: 2023-01-13
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: 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.

## Related Officers

- [Albert L. Nguyen](https://www.keypedia.com/people/albert-l-nguyen/496338d0-71c4-43da-92f0-09515559d9fc)

Company: https://www.keypedia.com/companies/electromed-inc/2e0611e6-8d86-449f-92c2-322112b6169a

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d