ACUPUNCTURE NEEDLE UNDER THE BRAND NAME HWATO AND HUAXIA

K974122 · Scientific Health Care · MQX · Jan 22, 1998 · General Hospital

Device Facts

• Record ID: K974122
• Device Name: ACUPUNCTURE NEEDLE UNDER THE BRAND NAME HWATO AND HUAXIA
• Applicant: Scientific Health Care
• Product Code: MQX · General Hospital
• Decision Date: Jan 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5580
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

HWATO and HUAXIA acupuncture needles are used to pierce skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.

Device Story

Device consists of acupuncture needles branded as HWATO and HUAXIA. Used by qualified acupuncture practitioners to pierce skin for therapeutic purposes. Device functions as a manual instrument for acupuncture practice. No electronic, software, or automated components involved. Clinical benefit derived from traditional acupuncture application.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual acupuncture needles. No energy source, connectivity, or software. Sterilization method not specified in document.

Indications for Use

Indicated for use by qualified acupuncture practitioners to pierce skin for acupuncture therapy. No specific age or gender restrictions provided.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 2 1998

Henry Woo, Ph.D. Scientific Health Care, Incorporated 1491 Baker Street, Suite 1 Costa Mesa, California 92626

Re : K974122 Trade Name: Acupuncture Needle Under The Brand Name Hwato and Huaxia Regulatory Class: II Product Code: MOX Dated: December 8, 1997 Received: December 11, 1997

Dear Dr. Woo:

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, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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. ಗಳ substantially equivalent determination assumes compliance with ---the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory 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

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Paqe 2 - Dr. Woo

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally 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 regulation (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.fdg.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulazowski
Director

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

Enclosure

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## Indications For Use

510(k) Number (if known)_ K974122 acupuncture needle under the brand names HWATO Device Name: દ્વ HUAXIA Indications For Use: HWATO & HUAXIA two brand names --

HWATO and HUAXIA acupuncture needles are used to pierce skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricin Caccende

(Division Sion-Off) Division of Dental, Info lon Control. and General Hos 510(k) Number

Prescription Use

OR

Over-The-Counter Use

(Optional Format 1-2-96)

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