TRICOT BLOOD PRESSURE CUFF

K051539 · Ya Horng Electronic Co., Ltd. · DXQ · Aug 5, 2005 · Cardiovascular

Device Facts

• Record ID: K051539
• Device Name: TRICOT BLOOD PRESSURE CUFF
• Applicant: Ya Horng Electronic Co., Ltd.
• Product Code: DXQ · Cardiovascular
• Decision Date: Aug 5, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1120
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The TRICOT blood pressure cuff is used in conjunction with non-invasive blood pressure measurement systems by personnel properly trained. The device is non-sterile and is intended as a reusable multi-patient device for measuring one's blood pressure. It is available in child through large adult sizes.

Device Story

Tricot blood pressure cuff; reusable multi-patient accessory for non-invasive blood pressure measurement systems. Device wraps around patient limb; functions as pneumatic interface to transmit pressure signals to external blood pressure monitor. Used in clinical settings by trained personnel. Provides physical containment for inflatable bladder; enables accurate oscillometric or auscultatory measurement. Benefits patient by facilitating routine blood pressure monitoring.

Clinical Evidence

Bench testing only.

Technological Characteristics

Reusable blood pressure cuff; tricot material construction; available in child through large adult sizes. Non-sterile. Interfaces with non-invasive blood pressure measurement systems via pneumatic connection.

Indications for Use

Indicated for use in child through large adult populations for non-invasive blood pressure measurement when used with compatible measurement systems by trained personnel.

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

• KTJ-20C GOLDEN HORSE MEDICAL EQUIPMENT (K010686)

Submission Summary (Full Text)

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K051539
page 1 of 1

AUG 5 - 2005

No. 35, Zsha Lun, Jon Zsha village, Antin Shiang, Tainan, Taiwan, ROC Tel: [phone] Fax: [phone] E-mail: [e-mail]

## 3. SUMMARY OF SAFETY AND EFFECTIVENESS

( According to 21 CFR 807.92)

| DATE OF<br>SUBMISSION: | May 22, 2005 |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SUBMITTER: | General Manager, Mr. HSU, SHENG HSIUNG<br>YA HORNG ELECTRONIC CO., LTD. |
| | No 35, Zsha Lun<br>Jon Zsha Village, |
| | Antin Shiang, Tainan, CHINA (TAIWAN) 745 |
| | TEL: [phone]<br>FAX: [phone] |
| ESTABLISHMENT<br>REGISTRATION NO: | 3001147827 |
| OFFICIAL<br>CONTACT: | Dr. JEN, KE-MIN<br>ROC CHINESE-EUROPEAN INDUSTRIAL RESEARCH<br>SOCIETY |
| | NO 58, FU-CHIUN ST. |
| | HSIN-CHU CITY, CHINA (TAIWAN) 30067 |
| | TEL: [phone] |
| | FAX:[phone] |
| TRADE NAME: | TRICOT BLOOD PRESSURE CUFF |
| COMMON/USUAL<br>NAME: | BLOOD PRESSURE CUFF |
| CLASSIFICATION<br>NAME: | CUFF, BLOOD PRESSURE (CFR870.1120) |
| CLASSIFICATION<br>PANEL: | CARDIOVASCULAR |
| PREDICATED<br>DEVICE: | KTJ-20C GOLDEN HORSE MEDICAL EQUIPMENT<br>(K010686) |
| INTENDED USE: | The TRICOT blood pressure cuff is used in conjunction<br>with non-invasive blood pressure measurement systems by<br>personnel properly trained. The device is non-sterile and is<br>intended as a reusable multi-patient device for measuring<br>one's blood pressure. It is available in child through large<br>adult sizes |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

AUG 5 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ya Horng Electronic Co.,Ltd. c/o Dr. Jen Ke-Min Official Correspondent No.35, Zsha Lun, Jon Zsha Village Antin Shiang, Tainan, China Taiwan, 745

Re: K051539

Trade Name: Ya Horng Blood- Pressure Cuff, Tricot Regulation Number: CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II (two) Product Code: DXQ Dated: June 6, 2005 Received: June 10, 2005

Dear Dr. Ke-Min:

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 application (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 II (Special Controls) or class III (PMA), it may be subject to such 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. Shu-Mei Wu

Please be advised that FDA's issuance of a substantial equivalence determination does 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 agenciess_ 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 Erth in the quality systems (QS) 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 begin 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 Compliance at [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/industry/support/index.html.

Sincerely yours,

Въпишитогров

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

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Image /page/3/Picture/0 description: The image shows the name of a company, Ya Horng CO., LTD., in bold, black letters. Below the company name is the address, No. 35. Zsha Lun, Jon Zsha village, also in black letters. The company name is much larger than the address, making it the focal point of the image. The text is clear and easy to read.

Antin Shiang, Tair Tel: [phone] htm:// www.vahomg.com E-mail: [e-mail]

## INDICATIONS FOR USE STATEMENT 2.

## Indications for Use

510(k) Number:

TBA K05/539

Device Name:

YA HORNG ELECTRONIC CO., LTD. BLOOD-PRESSURE CUFF, TRICOT

## INTENDED USE

The TRICOT blood pressure cuff is used in conjunction with non-invasive blood pressure measurement systems by personnel properly trained. The device is non-sterile and is intended as a reusable multi-patient device for measuring one's blood pressure. It is available in child through large adult sizes.

Prescription Use __ Y (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bhumma
Division Sign Off

(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number 19.915.

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