Astek Technology , Ltd.

Astek Technology, Ltd. specializes in transcutaneous electrical nerve stimulation (TENS) and electrical muscle stimulation (EMS) devices. These systems are designed to deliver controlled electrical impulses through external electrode pads to either manage pain (TENS) or stimulate muscle activity (EMS). The company focuses exclusively on these non-invasive electrical therapy solutions.

Astek Technology, Ltd. is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. Specifically, the company’s products fall under the FDA’s Class II classification, which requires pre-market clearance via the 510(k) pathway to demonstrate substantial equivalence to a legally marketed predicate device.

Astek Technology, Ltd.’s devices are listed in the U.S. Food and Drug Administration’s (FDA) 510(k) clearance registry. This registry documents the pre-market submissions required for Class II devices, ensuring transparency about their compliance with FDA requirements before commercial distribution.

Astek Technology, Ltd.’s devices are classified as Class II under FDA regulations. This classification is based on the agency’s risk-based framework, where Class II devices pose moderate risk and require special controls (such as performance standards or post-market surveillance) in addition to general controls. The company’s TENS and EMS stimulators fall into this category due to their intended use for therapeutic purposes, requiring pre-market clearance via the 510(k) process.