Needle, acupuncture, single-use

Intended purpose

Intended Purpose Statement – Disposable Sterile Press Needle. The disposable sterile press needle is a single-use acupuncture device intended to puncture the skin at specific anatomical points for therapeutic stimulation in accordance with traditional acupuncture principles. It is designed for transient, minimally invasive contact and is used by trained healthcare professionals to promote physiological balance, relieve pain, and support musculoskeletal or neurological treatment protocols. The needle is manufactured from 06Cr19Ni10 (SUS304) stainless steel wire per GB/T 4240-2009, with a sharp, rounded tip free of burrs or hooks. It exhibits a hardness of ≥450HV0.2 and a surface roughness (Ra) ≤0.4 µm. Dimensional tolerances are tightly controlled across a range of specifications (0.16–0.26 mm diameter; 0.9–3.0 mm length). A tightly wound ring (1–2 loops) is vertically aligned with the needle shaft for secure placement. Sterilization is achieved via validated ethylene oxide (EO) processes, with EO residue ≤10 µg/g (GB/T 14233.1-2008). Sterility is confirmed per the Chinese Pharmacopoeia 2015 Edition. The device demonstrates corrosion resistance through immersion and boiling tests. The press needle is designed to remain in situ for short-term therapeutic effect, with a maximum dwell time of up to but no longer than 28 consecutive days. It is not intended for implantation beyond this period and must be removed and discarded after use. The product aligns with GMDN code 34175 – Acupuncture needle, single-use, and meets the requirements for Class IIa classification under the Therapeutic Goods (Medical Devices) Regulations.