Performance Health Supply, LLC

Performance Health Supply, LLC specializes in a variety of medical devices, including single-use transcutaneous electrical stimulation electrodes, acupuncture needles, and localized-body heating systems. Their portfolio also includes drug-delivery iontophoresis patches, topical coupling gels for skin, clinical external manual massagers, paraffin wax baths for physical therapy, and aneroid manual sphygmomanometers. Additionally, they produce patient support items like gel padding and stockinette materials, as well as assistive utensils designed for easier handling.

Performance Health Supply, LLC is based in the United States. Their devices are listed in the FDA’s Unique Device Identifier (UDI) database and EUDAMED, which are key registries for tracking medical devices in the U.S. and European Union, respectively. Listing in these databases helps ensure compliance with regulatory requirements and transparency for healthcare providers.

The devices produced by Performance Health Supply, LLC fall into two primary regulatory classes: Class I and Class II. Class I devices generally pose minimal risk and may require fewer regulatory controls, while Class II devices involve a higher level of risk and typically require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body area it interacts with.

Performance Health Supply, LLC’s devices serve a mix of therapeutic and supportive purposes. Therapeutic devices in their portfolio include transcutaneous electrical stimulation electrodes, acupuncture needles, iontophoresis patches, heating systems, and physical therapy tools like paraffin wax baths and massagers. Meanwhile, items like gel padding, stockinette, and assistive utensils are designed to support patient comfort, mobility, and independence rather than diagnose or treat medical conditions.