# FDA 483 - Excel Medical Electronics LLC - December 19, 2025

Source: https://www.keypedia.com/records/483/excel-medical-electronics-llc/74e30dd9-54c4-41d2-8a48-48e4fc7f0920

> FDA 483 for Excel Medical Electronics LLC on December 19, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Excel Medical Electronics LLC
- Inspection Date: 2025-12-19
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Excel Medical Electronics LLC, a manufacturer of medical electronics, was inspected and cited for deficiencies in its quality system. The inspection revealed inadequate procedures for design verification, specifically regarding the Wave Clinical Platform Software, and an insufficient risk analysis that failed to include pertinent risks and mitigation actions related to software configuration. These issues indicate a need for improved quality system controls.

## Related Documents

- [483 - 2019-03-13](https://www.keypedia.com/records/483/excel-medical-electronics-llc/100ae121-5ea6-4601-8c61-e50fe2a19625)
- [483 - 2019-03-13](https://www.keypedia.com/records/483/excel-medical-electronics-llc/9539abb3-130d-4fc3-928c-df1bc0f482c8)

## Related Officers

- [Gisselle I. Sensebe](https://www.keypedia.com/people/gisselle-i-sensebe/fbf83976-9888-44c0-a381-1993a933df4a)

Company: https://www.keypedia.com/companies/excel-medical-electronics-llc/ba31f7fc-d704-4031-b0a2-b71e6d70cc46

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6