MULTIPLE, MODEL KTJ-50

K043444 · Golden Horse Medical Equipment (Wuxi) Co. , Ltd. · DXQ · Feb 22, 2005 · Cardiovascular

Device Facts

• Record ID: K043444
• Device Name: MULTIPLE, MODEL KTJ-50
• Applicant: Golden Horse Medical Equipment (Wuxi) Co. , Ltd.
• Product Code: DXQ · Cardiovascular
• Decision Date: Feb 22, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1120
• Device Class: Class 2

Intended Use

The Multiple Brand, with model number KTJ-50, aneroid sphygmomanometer is an instrument intended to be used for the indirect (noninvasive) measurement of human's Systolic, Diastolic blood pressure using the auscultatory method by detecting Korotkoff Sound. This device is to be used by trained medical and health care personnel or trained general users.

Device Story

Aneroid sphygmomanometer (Model KTJ-50) for non-invasive blood pressure monitoring. System components: aneroid manometer, latex bulb, cuff, valve, and stethoscope. Operation: user places stethoscope on inner arm above elbow; inflates cuff; performs auditory monitoring of Korotkoff sounds via stethoscope to evaluate systolic and diastolic pressure. Used by trained medical personnel or trained general users in clinical or home settings. Output is manual reading of systolic/diastolic values. Benefits patient through routine blood pressure monitoring.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Aneroid sphygmomanometer consisting of manometer, latex bulb, cuff, valve, and stethoscope. Manual operation; non-electronic; no software or energy source.

Indications for Use

Indicated for non-invasive measurement of systolic and diastolic blood pressure in humans using the auscultatory method. Intended for use by trained medical personnel or trained general users.

Regulatory Classification

Identification

A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.

Predicate Devices

• Mabis brand and Mabis customers private label brand (K942072)

Submission Summary (Full Text)

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FEB & 2 2005

K04344
P 1/2

# 510(K) Summary

Submitter

George Su Crosslinks International 1800 Century Park East, Suite 600 Los Angeles, CA 90067 USA

Tel: [phone] Fax: [phone] Email: [e-mail]

#### Manufacturer:

Golden Horse Medical Equipment (Wuxi) Co., Ltd. 42 Xi Xin Road, Zhang Jing Town, Wuxi City, P. R. China 214194

Tel: [phone] Fax: [phone] Email: ghmed(@)publicl.wx.js.cn

### Device Name:

Proprietary Name: Multiple Common/Usual Name: Aneroid Sphygmomanometer Device Name: Non-invasive Blood-pressure Measurement System Product Code: DXN Classification: Class II

# Predicate Device:

Mabis brand and Mabis customers private label brand Establishment: MABIS HEALTHCARE, INC. Regulation Number : 890.5500 Product Code : DXN 510(k) Number: K942072 Registration Number: 1422443 Owner/Operator Number: 9005245

# Description of the Multiple Brand KTJ-50:

The aneroid sphygmomanometer with stethoscope is a non-invasive blood pressure measurement system for

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monitoring blood pressure levels which can be performed by trained individuals. The sphygmomanometer Model KTJ-50 consists of 5 parts. They are aneroid manometer, latex bulb, cuff, valve and stethoscope set. The aneroid sphygmomanometer with stethoscope enables the user places the attached stethoscope on the inner arm above the bend in the elbow, to detect the Korotkoff sound. After inflation of the user does auditory monitor with the stethoscope to evaluate systolic and diastolic pressure. The two values are recorded as: systolic over diastolic.

#### Intended Use

The Multiple Brand KTJ-50 is an aneroid sphygmomanometer intended to be used for the indirect (noninvasive) measurement of the arterial blood pressure by trained medical and health care personnel or trained general users.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The symbol is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 7 - 2005

Golden Horse Medical Equipment (Wuxi) Co., Ltd. c/o Mr. George Su Crosslinks International, Inc. 1800 Century Park East, Suite 600 Los Angeles, CA 90067

Re: K043444

Trade Name: Multiple, Model KTJ-50 Regulation Number: 21 CFR 870.1120 Regulation Name: Blood-Pressure Cuff Regulatory Class: Class II Product Code: DXQ Dated: February 09,2005 Received: February 10,2005

Dear Mr. Su:

This letter corrects our substantially equivalent letter of February 22,2005, regarding the regulation number, regulation name, and product code.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval (PMA). 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 11 (Special Controls) or class III (PMA). it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. George Su

Please be advised that FDA's issuance of a substantial equivalence determination doks not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to continue marketing your device as described in your Section 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), please contact the Office of Complianceat [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

B bimuma for
Bram D. Zuckerman, M.D.

Bram D. Zuckerman, M.D Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number(if known): K043444

Device Name : Non-invasive Blood Pressure Measurement System

Indications for Use:

The Multiple Brand, with model number KTJ-50, aneroid sphygmomanometer is an instrument intended to be used for the indirect (noninvasive) measurement of human's Systolic, Diastolic blood pressure using the auscultatory method by detecting Korotkoff Sound. This device is to be used by trained medical and health care personnel or trained general users.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED |

Concurrence of CDRH, Office of Device Evaluation(ODE)

Blumensone

IDWslon Sign-Off) Division of Cordiovascular Deyices 510(k) Numbor_

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(Posted November 13, 2003)