Sharperimage

Sharperimage produces transcutaneous electrical stimulation electrodes (single-use), transcutaneous electrical stimulation leads, and physical therapy systems for transcutaneous neuromuscular electrical stimulation (TENS). These devices are designed to manage pain and stimulate muscles using electrical impulses delivered through electrodes and leads.

Sharperimage is based in the United States. The company’s headquarters and operations are located within the country.

Yes, Sharperimage’s devices are listed under the FDA’s Unique Device Identifier (UDI) system. This registry helps track and identify medical devices for regulatory and market surveillance purposes.

Sharperimage’s transcutaneous electrical stimulation devices fall under the FDA’s Class II classification. This classification is assigned based on the level of risk associated with the device, with Class II indicating moderate risk that requires special controls to ensure safety and effectiveness.