Perin Health Devices, LLC - FDA 510(k) Cleared Devices

Perin Health Devices, LLC develops wearable medical devices and integrated care management systems for remote patient monitoring. The company is based in Oklahoma City with FDA-registered manufacturing operations in the same location. Their flagship product, the Health Patch, is a multi-modal wearable that monitors up to 15 vital metrics simultaneously.

The company has received 1 FDA 510(k) clearance from 1 total submission, with all submissions focused on Cardiovascular devices. The latest clearance was in 2026, confirming active regulatory engagement and current market presence. The Health Patch represents the company's core innovation in wearable monitoring technology.

Perin Health's product ecosystem includes the Health Patch wearable sensor and the Provider Portal, a cloud-based care management application. The system integrates with electronic health records and third-party clinical devices to support outpatient, inpatient, and long-term care monitoring. The company emphasizes ease of use, water resistance, extended battery life, and comprehensive vital sign capture across diverse clinical settings.

Explore the company's FDA 510(k) clearance history, device names, product codes, and clearance dates in the regulatory database.

510(k) submissions have been managed by Rook Quality Systems as regulatory consultant.