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Acupuncture Needles

FDA 510(k)

Class II (US FDA 510(k))

510(k) K041652

by C A I Industries Corp

Identifiers

510(k) Number
K041652 FDA 510(k)
FDA Product Code
MQX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5580 FDA 510(k)
Regulation Number
880.5580 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Acupuncture Needles are sterile, single-use medical devices designed for acupuncture procedures. These needles are intended for insertion into the skin at specific acupuncture points to stimulate nerve bundles and promote natural healing, pain relief, or other therapeutic effects as part of traditional acupuncture therapy.

These needles are supplied in sterile packaging for clinical use in general hospital settings. They are classified as Class II devices under FDA regulations and are intended for single-use only. The product is available in various sizes and reference codes, as listed in the regulatory submission (e.g., 3005417950, 3012449047). No reusable or MRI-compatible variants are indicated in the specifications.

Frequently asked questions

What are these acupuncture needles used for?

These needles are designed for acupuncture procedures to stimulate nerve bundles at specific acupuncture points. The goal is to promote natural healing, pain relief, or other therapeutic effects as part of traditional acupuncture therapy. They are not intended for any other medical purpose beyond their designated use.

How are these needles supplied and what is their sterility status?

The needles are supplied in sterile packaging specifically for clinical use in general hospital settings. Each package is individually sterilized to ensure safety for single-use only, preventing cross-contamination between patients.

Are these needles reusable or intended for single-use?

These needles are explicitly intended for single-use only. Reuse is not recommended or approved, as it could compromise sterility and patient safety. The packaging is designed to maintain sterility until the first and only use.

What sizes or reference codes are available for these acupuncture needles?

These needles are available in multiple sizes and reference codes, including but not limited to: 3005417950, 3012449047, 3000143502, 3003110073, and others listed in the regulatory submission. The exact size or gauge may vary by reference code, so verifying the specific code is important for clinical application.

How should these needles be stored to maintain their integrity?

The needles should be stored in their original, unopened sterile packaging to preserve sterility. They must be kept in a clean, dry environment, protected from direct sunlight, extreme temperatures, and physical damage. Avoid storing them in areas with high humidity or where they may be exposed to contaminants.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Acupuncture Needles | CAI Corporation, Acupuncture Supplies | CAI Corporation, RevMed Marketplace | Connecting the Dots, CAI Acupuncture Needles | El Monte CA - Facebook, C. A. I. Corporation | (626) 448-6622 | South El Monte, California - AllBiz

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
C A I Industries Corp
FDA Applicant
C.A.I. Industries Corp.

Sources (1)

  • FDA 510(k) K041652 24 fields · synced Oct 1, 2026