# FDA 483 - Pro2Health, Inc. - December 18, 2025

Source: https://www.keypedia.com/records/483/pro2health-inc/15f70e36-1069-4ab8-9222-2011de91195d

> FDA 483 for Pro2Health, Inc. on December 18, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pro2Health, Inc.
- Inspection Date: 2025-12-18
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Pro2Health, Inc. in Lakewood, OH, a medical device manufacturer, identified two significant observations. The firm failed to adequately verify design outputs against inputs, specifically lacking justification for numerous failing tests. Additionally, Pro2Health, Inc. did not provide the required Unique Device Identification (UDI) for its class 2 respiratory muscle training device.

## Related Officers

- [Investigator ](https://www.keypedia.com/people/laureen-m-geniusz/759a858e-e3f3-4c48-8194-9804c7ab2a7b)

Company: https://www.keypedia.com/companies/pro2health-inc/64a2210c-f032-44f8-bc16-5595e40dc386

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22