483
OxiWear Inc.OxiWear Inc. – FDA 483, Jul 30, 2025
Record Details
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.
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