Acu Market

Acu Market specializes in single-use acupuncture needles. Their product line includes standard disposable acupuncture needles for traditional acupuncture, as well as semi-permanent auricular needles designed specifically for ear acupuncture. Examples include lightweight 'featherlite' needles, J-type needles, and bulk packs for clinical settings. These devices are tailored for use in acupuncture practices.

Acu Market is based in the United States. Since they operate within the US, their devices must comply with FDA regulations. The company’s products are classified as Class II under FDA guidelines, which means they undergo specific controls to ensure safety and effectiveness before being listed in regulatory databases like the FDA’s Unique Device Identifier (UDI) system.

Yes, Acu Market’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This matters because the UDI system provides a standardized way to identify medical devices, improving traceability, safety monitoring, and regulatory oversight. Listing in the UDI database ensures transparency and helps healthcare providers, regulators, and manufacturers track devices throughout their lifecycle.

Acu Market’s acupuncture needles are classified as Class II devices under FDA regulations. This classification means they are subject to special controls beyond general controls, such as performance standards or post-market surveillance, to ensure their safety and effectiveness. Class II classification is common for devices that pose moderate risk and require additional oversight without requiring pre-market approval.