KEY ELECTRONICS, INC.

Key Electronics, Inc. specializes in acupuncture electrical stimulation systems. Their portfolio includes devices like the IB-STIM and NSS Neurostim, which deliver periauricular nerve stimulation to help manage opioid withdrawal symptoms and irritable bowel-related discomforts. These devices use electrical stimulation to target specific nerve pathways for therapeutic relief.

Key Electronics, Inc. is based in the United States. Since the FDA regulates medical devices in the U.S., the company’s devices must comply with FDA requirements. Their products are listed in the FDA’s Unique Device Identifier (UDI) database, which helps track and monitor devices authorized for use in the U.S. market.

Key Electronics, Inc.’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices authorized for sale in the U.S., ensuring transparency and traceability for healthcare providers and regulators.

Key Electronics, Inc.’s devices fall under two FDA classification categories: Class II and Unclassified (U). Class II devices generally pose moderate risk and require special controls to ensure safety and effectiveness, while Unclassified devices may require additional review or have unique regulatory pathways depending on their intended use and risk profile.

Key Electronics, Inc. designs acupuncture electrical stimulation systems primarily for therapeutic nerve modulation. Their devices, such as the NSS MFS and NSS-2, are intended to provide relief for opioid withdrawal symptoms and irritable bowel-related discomforts by stimulating specific periauricular nerves. These systems are engineered to deliver targeted electrical stimulation for symptom management.