ADDIQUIP DISPOSABLE ACUPUNCTURE NEEDLES

K981272 · Electro Therapeutic Devices, Inc. · MQX · Aug 24, 1998 · General Hospital

Device Facts

• Record ID: K981272
• Device Name: ADDIQUIP DISPOSABLE ACUPUNCTURE NEEDLES
• Applicant: Electro Therapeutic Devices, Inc.
• Product Code: MQX · General Hospital
• Decision Date: Aug 24, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5580
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.

Device Story

ADDIQUIP disposable acupuncture needles are stainless steel needles used by qualified practitioners to pierce the skin during acupuncture therapy. The device is provided in sterile, individual blister packs, with 100 needles per box. The needles are sterilized using ethylene oxide (ETO). The device is intended for professional use only, restricted by federal law to sale by or on the order of qualified practitioners as determined by state regulations.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Stainless steel disposable acupuncture needles; sterilized via ethylene oxide (ETO); available in various metric and imperial sizes (e.g., 0.22 x 40mm, 1" ga. 34).

Indications for Use

Indicated for use by qualified acupuncture practitioners to pierce the skin for acupuncture therapy.

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.

Predicate Devices

• CARBO acupuncture needles (K961339)

Submission Summary (Full Text)

{0}------------------------------------------------

K98/272

AUG 2 4 1998

Image /page/0/Picture/2 description: The image shows a logo for E.T.D. INC. The logo consists of a square with a wavy line running through the top portion of the square. Below the square, the letters "E.T.D. INC." are printed in a sans-serif font. Below that, the words "ELECTRO-THERAPEUTIC DEVICES INC." are printed in a smaller sans-serif font.

510(k) SUMMARY.

Name of device: ADDIQUIP disposable Acupuncture needles. K981272. Product code: MQX. Classification panel : 80.

Submitter's Name; Electro Therapeutic Devices Inc. 570 Hood Road, ste.14, Markham, Ont. Canada L3R 4G7. tel. no. [phone]. fax no. 905 475 5143.

Date:

28th July 1998.

Manufacturer's Name & Address: wu xihou ZHAI M.E. Factory, WUXI, JIANG SHU, China.

Comparison to a legally marketed device: CARBO(k961339) acupuncture needles from China. Enclosed photocopy of their packaging.

## CARBO

## ADDIQUIP.

Stainless steel disposable acupuncture needles.

Made in China.

Sterilized by ETO.

CAUTION LABEL:Federal law restricts this device to sale by or on the order of qualified practitioners of acupuncture asdetermined by the states.

Size description of needles both in metric and imperial ie. 0.22 x 40mm and 1"ga.34.

Sterile expiry date & lot no. Packing: 100 needles per box. Each needle in sterile,blister pack.

Stainless steel disposable acupuncture needles.

Made in China

Sterilized by Ethylene Oxide

Similar

Similar

Similar

[] 570 Hood Road, Suite 14, Markham, Ontario, Canada L3R 4G7 [] Tel .: [phone] [phone] [ Toll Free: 1-800-268-3834 [ E-mail: [e-mail]

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines. The overall design is simple and monochromatic.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 4 1998

Mr. K. C. Choong President Electro-Therapeutic Devices, Incorporated 570 Hood Road, Suite 14 Markham, Ontario CANADA L3R4G7

Re : K981272 Trade Name: ADDIQUIP Disposable Acupuncture Needles Regulatory Class: II Product Code: MOX Dated: July 28, 1998 Received: July 30, 1998

Dear Mr. K. C. Choong:

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 legally marketed predicate 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 qeneral 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 aqainst 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. ਧੋ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

{2}------------------------------------------------

Page 2 - Mr. K. C. Choong

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

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 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 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"(21CFR 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/dsma/dsmamain.html".

Sincerely yours,

S. Butman for

Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure. 11 - 1 - 1 - 1 - 1 --

{3}------------------------------------------------

K9811212

Image /page/3/Picture/1 description: The image shows a logo with a square border. Inside the square, there is a thick, curved line. Below the square, the text "E.T.D. INC." is printed in a stylized font. Underneath that, the words "ELECTRO-THERAPEUTIC DEVICES INC." are printed in a smaller, simpler font.

## INDICATION for USE statement.

ADDIQUIP disposable acupuncture needles: K981272.

"To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States."

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The-Counter Use -------(Optional Format 1-2-96) (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _

: : 570 Hood Road, Suite 14, Markham, Ontario, Canada L3R 4G7 □ Toll Free: 1-800-268-3834 0 Fax: [phone]

[] Tel.: [phone] [phone] [ E-mail: [e-mail]