ZetrOZ Systems, LLC - FDA 510(k) Cleared Devices

ZetrOZ Systems, LLC is a medical device manufacturer headquartered in Trumbull, Connecticut. The company develops and manufactures wearable ultrasound devices for non-invasive tissue healing and pain management. ZetrOZ specializes in sustained acoustic medicine (sam®) technology for acute and chronic musculoskeletal conditions.

ZetrOZ has received 5 FDA 510(k) clearances from 5 total submissions since its first clearance in 2020. The company focuses exclusively on Physical Medicine devices. Its latest FDA 510(k) clearance was in 2026, demonstrating continued regulatory activity and product innovation.

The sam® product line includes multi-hour continuous ultrasound devices designed for wearable, long-duration therapeutic delivery. These devices are supported by over 46 patents and are manufactured entirely in the United States under cGMP and ISO 13585 standards.

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