True Wearables, Inc.

True Wearables, Inc. specializes in pulse oximeters, such as the Oxxiom series. These devices are designed for non-invasive monitoring of blood oxygen saturation (SpO₂) and pulse rate, commonly used in clinical and home healthcare settings to track respiratory and cardiovascular health.

True Wearables, Inc. is headquartered in the United States. The company’s location ensures compliance with U.S. regulatory standards for medical devices, including those governed by the FDA.

True Wearables, Inc.’s devices are listed in the FDA’s 510(k) premarket notification registry and the FDA’s Unique Device Identifier (UDI) system. These registries track devices that have undergone the required regulatory pathways for market authorization in the U.S.

True Wearables, Inc.’s pulse oximeters, including the Oxxiom series, are classified as Class II devices under FDA regulations. This classification applies to devices that generally pose moderate risk and require special controls to ensure their safety and effectiveness, such as performance standards or post-market surveillance.