Cognito Health Inc.

Cognito Health Inc. specializes in two primary device categories: nurse call system alarms and pressure/vibration sensors for beds and chairs. These devices are engineered to enhance patient safety in healthcare environments by alerting caregivers when a patient needs assistance or when movement is detected, ensuring timely intervention.

Cognito Health Inc. is headquartered in the United States. The company’s location influences its regulatory compliance framework, as it operates under FDA guidelines for medical device authorization.

Cognito Health Inc.’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the supply chain, allowing healthcare providers and regulators to verify device details, such as manufacturer information and classification.

Cognito Health Inc.’s devices are classified as Class I medical devices by the FDA. This classification applies to products posing minimal risk to patients and users, often involving general controls like good manufacturing practices and labeling requirements. The classification reflects the low-risk nature of nurse call alarms and pressure/vibration sensors.