# FDA 483 - OxiWear Inc. - July 30, 2025

Source: https://www.keypedia.com/records/483/oxiwear-inc/6ec0cc9e-86f9-400e-8634-aca439410709

> FDA 483 for OxiWear Inc. on July 30, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: OxiWear Inc.
- Inspection Date: 2025-07-30
- Product Type: device
- Office Name: New York District Office
- Summary: An FDA inspection of OxiWear Inc. in Buffalo, NY, a medical device manufacturer, identified a significant deficiency in design input documentation. The firm failed to adequately document design input requirements for its OxiWear OxiV3 Ear-Wearable Continuous SpO2 Data Collection System, specifically concerning its intended use across all skin types. This indicates a moderate severity concern regarding the foundational design controls for their medical device.

## Related Officers

- [Matthew D. Schnittker](https://www.keypedia.com/people/matthew-d-schnittker/cf76f07f-db6d-47a0-8412-7eb084d4fe8b)

Company: https://www.keypedia.com/companies/oxiwear-inc/001aab9f-2beb-4064-ba3d-c22fffc42a3e

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d