Tai-Chi Acupuncture Needles

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K003760 ↗

FDA Product Code

MQX

Device Class

Class II

Regulation

21 CFR Part 880.5580

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Tdp Cq-27 Heat Lamp

  Class II

  FDA 510(k) K003538 Active Cleared 4 Jun 2001

• Dbc Acupunture Needles(Several Types Are Described on the Following Pages)

  Class II

  FDA 510(k) K963300 Active Cleared 23 Sep 1996

• Taki Acupuncture Needles

  Class II

  FDA 510(k) K964411 Active Cleared 31 Dec 1996

• Hua-Xia Acupuncture Needles

  Class II

  FDA 510(k) K962916 Active Cleared 23 Aug 1996

• Dbc Press Acupuncture Needles

  Class II

  FDA 510(k) K031250 Active Cleared 15 Jul 2003

• Tai-Chi and Master Acupuncture Needles

  Class II

  FDA 510(k) K023787 Active Cleared 14 Feb 2003

See all devices from Lhasa Medical, Inc. →

• Are these needles reusable, or are they meant for single-use only in clinical settings?

  The Tai Chi Acupuncture Needles from Lhasa Medical, Inc. are explicitly designed for single-use only. They are supplied sterile and labeled as disposable, adhering to clinical standards for acupuncture to prevent cross-contamination and ensure patient safety. Reuse is not recommended or supported by the manufacturer.

• What materials are the needles and handles made from, and do they offer any special features?

  The needles are manufactured from surgical stainless steel, while the handles are made from copper and may feature silver-plating or gold-plating for enhanced conductivity. This design supports applications like moxibustion or electro-therapy, where improved electrical flow may be beneficial. The spiral-wound handle also includes a loop for secure grip during use.

• How should these needles be stored to maintain their sterility and integrity?

  Since these needles are sterile and single-use, they must be stored following sterile medical device protocols to preserve their integrity. The manufacturer does not specify packaging details, but standard practices for acupuncture needles—such as sealed, moisture-resistant packaging and protection from physical damage—should be followed. Always check the packaging for storage instructions before use.

• What regulatory pathway was followed for FDA clearance, and what does that mean for clinicians?

  The Tai Chi Acupuncture Needles received FDA 510(k) clearance under the MQX product code (Class II) and were determined to be substantially equivalent to traditional acupuncture needles. This means the device meets FDA standards for safety and effectiveness as a single-use acupuncture needle and is classified for use in general hospital settings. Clinicians can rely on this clearance as evidence of compliance with U.S. regulatory requirements for acupuncture needles.

• Are there different sizes or models available, and how would I identify them?

  The Tai Chi Acupuncture Needles come in multiple FEI-numbered models (e.g., 3005417950, 3033906329, etc.), which likely correspond to variations in length, gauge, or handle design. While the exact specifications (e.g., needle length) aren’t detailed in the data, the spiral-wound handle with a loop is a consistent feature. Clinicians should refer to the packaging or manufacturer’s documentation for precise sizing details, as these variations may influence acupuncture point targeting or patient comfort.