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Hua-Xia Acupuncture Needles

by Lhasa Medical, Inc.

510(k) K962916

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 NumberK962916 Date23 Aug 1996ClearedStatusActive

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  • Withdrawn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.

Acupuncture needles are devices used to stimulate specific points on the body for therapeutic purposes. The Hua-Xia Acupuncture Needles are single-use, sterile needles intended for acupuncture procedures.

These needles are supplied sterile and are intended for single-use only. They are regulated as Class II medical devices under FDA 510(k) clearance (K962916) and are used in general hospital settings.

Other devices from Lhasa Medical, Inc.

See all devices from Lhasa Medical, Inc. →

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 are Hua-Xia Acupuncture Needles used for?

    Hua-Xia Acupuncture Needles are used to stimulate specific points on the body for therapeutic purposes during acupuncture procedures, as stated in the device description.

  • Are Hua-Xia Acupuncture Needles sterile and single-use?

    Yes, the Hua-Xia Acupuncture Needles are supplied sterile and intended for single-use only, as explicitly specified in the device data.

  • What regulatory clearance do Hua-Xia Acupuncture Needles have?

    Hua-Xia Acupuncture Needles are regulated as Class II medical devices under FDA 510(k) clearance with K-number K962916, as indicated in the authorizations and openfda fields.