Optima Health Solutions International, Inc.

Optima Health Solutions International, Inc. specializes in physical therapy ultrasound systems. These devices are primarily used for therapeutic interventions in musculoskeletal rehabilitation, helping patients recover from injuries or manage chronic conditions through targeted ultrasound therapy.

The company is headquartered in the United States. This location allows it to comply with U.S. regulatory requirements, including those for its Class II (U) devices, which are subject to FDA oversight.

Devices from Optima Health Solutions International, Inc., such as the Khan Kinetic Treatment Device (KKT-M2 and KKT-M1), are included in the FDA’s 510(k) premarket notification program and the Unique Device Identifier (UDI) system. These registries ensure traceability and compliance with U.S. medical device regulations.

The company’s devices, including its physical therapy ultrasound systems, fall under Class II (U) classification by the FDA. This classification means they pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.