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Jia Chen Acupuncture Needle, For Single Use

by Mandala Health Care, LLC

510(k) K023054

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK023054 Date13 Nov 2002ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MQX
Device Class
Class II
Regulation
21 CFR Part 880.5580
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

An acupuncture needle is a device intended for use in acupuncture procedures. This device is a single-use needle designed for insertion into the skin at specific points to stimulate therapeutic effects.

It is supplied sterile for single use only and is not intended for reuse. The device is authorized under FDA 510(k) clearance (K023054) and is classified as a Class II medical device under regulation number 880.5580.

Questions

AI-generated answers, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the JIA CHEN ACUPUNCTURE NEEDLE, FOR SINGLE USE intended for?

    This device is intended for use in acupuncture procedures, specifically for insertion into the skin at specific points to stimulate therapeutic effects. It is designed for single use only and is not meant to be reused.

  • How is the JIA CHEN ACUPUNCTURE NEEDLE supplied and is it sterile?

    The device is supplied sterile for single use only. It is not intended for reuse, ensuring patient safety by eliminating cross-contamination risks associated with reprocessing.

  • What regulatory authorization does the JIA CHEN ACUPUNCTURE NEEDLE have?

    The device is authorized under FDA 510(k) clearance with K number K023054 and is classified as a Class II medical device under regulation number 880.5580. It was found substantially equivalent to a predicate device.