KINGLI ACUPUNCTURE NEEDLE

K990406 · United Pacific Co., Ltd. · MQX · Apr 16, 1999 · General Hospital

Device Facts

• Record ID: K990406
• Device Name: KINGLI ACUPUNCTURE NEEDLE
• Applicant: United Pacific Co., Ltd.
• Product Code: MQX · General Hospital
• Decision Date: Apr 16, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5580
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

to pierce the skin in the practice of acupuncture by the states.

Device Story

Disposable acupuncture needle used by licensed practitioners to pierce skin for acupuncture therapy. Device consists of sterile, single-use needle. Practitioner inserts needle into patient's skin at specific acupuncture points to provide treatment. Device facilitates traditional acupuncture practice; intended for prescription use.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Disposable, sterile acupuncture needle. Class II device. Product code MOX.

Indications for Use

Indicated for use by qualified practitioners to pierce the skin in the practice of acupuncture.

Regulatory Classification

Identification

An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment.

Special Controls

*Classification.* Class II (special controls). The device, when it is an acupuncture point locator or a single use acupuncture needle, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9. Acupuncture needles must comply with the following special controls:(1) Labeling for single use only and conformance to the requirements for prescription devices set out in 21 CFR 801.109, (2) Device material biocompatibility, and (3) Device sterility.

Submission Summary (Full Text)

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Public Health Service

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APR 1 6 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Daniel Ye Hua President United Pacific Company, Limited 219 South Raymond Avenue Alhambra, California 91801

K990406 Re : Kingli Acupuncture Needle Trade Name: Regulatory Class: II Product Code: MOX February 5, 1999 Dated: February 9, 1999 Received:

Dear Mr. Hua:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Paqe 2 - Mr. Hua

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Diregtor Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K 990406

Page 10 of 36

510(k) Number (if known):_K990406

Device Name: DISPOSABLE ACUPUNCTURE NEEDLE

Indications For Use:

to pierce the skin in the practice of acupuncture by the states.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Palotcca Cucenith

(Division Sign-Off) Division of Denel, Infection Control, and General Hospital Devices

510(k) Number K990406

OR

Prescription Use V (Per 21 CFR 801.109) Over-The-Counter Use_

(Optional Format 1-2-96)