RTT DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL RTW-8010A

K060077 · Real Tone Technology Corp. · DXN · Mar 8, 2006 · Cardiovascular

Device Facts

• Record ID: K060077
• Device Name: RTT DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL RTW-8010A
• Applicant: Real Tone Technology Corp.
• Product Code: DXN · Cardiovascular
• Decision Date: Mar 8, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

Intended Use

RTT Digital Blood Pressure Monitor Model RTW-8010A is indicated for nonivasive measurement of systolic and diastolic blood pressure and determination of puslse rate from user's wrist .

Device Story

The Real Tone Digital Blood Pressure Monitor (Model RTW-8010A) is a noninvasive device designed for wrist-based blood pressure and pulse rate measurement. It functions by detecting arterial oscillations via a cuff-based sensor system. The device processes these signals to calculate systolic and diastolic blood pressure values and heart rate, displaying the results on an integrated digital screen. It is intended for use by individuals to monitor their own blood pressure in a home or clinical setting. The output provides users with immediate physiological data, facilitating self-monitoring of cardiovascular health and assisting in the management of hypertension.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Noninvasive oscillometric blood pressure monitor; wrist-worn cuff; digital display; battery-powered; software-controlled measurement algorithm.

Indications for Use

Indicated for noninvasive measurement of systolic and diastolic blood pressure and pulse rate from the wrist in adult users.

Regulatory Classification

Identification

A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal for the Department of Health and Human Services, USA. The seal is circular, with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. In the center of the seal is a stylized emblem consisting of three curved lines that resemble a human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2006 MAR 8

Real Tone Technology Corp. c/o Mr. Tom Wang 101 Room, NO 28, Lane 777 Xi Huang Road Xinzhuang Town, Shanghai

Re: K060077

K00007 /
Trade Name: Real Tone Digital Blood Pressure Monitor, Model RTW-8010A Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: November 12, 2006 Received: January 10, 2006

Dear Mr. Wang:

We have reviewed your Section 510(k) premarket notification of intent to market the device in diedic t we nave reviewed your becaon 310(x) premised is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 tise stated in the encrosule) to regard to the Medical Device Amendments, or to comments prices that have been reclassified in accordance with the provisions of the Federal Frod, DMA devices mat have been recuired in assee approval of a premarket approval application (PMA). and Costience Act (71ct) that the novice, subject to the general controls provisions of the Act. The I ou may, merciole, manot and act include requirements for annual registration, listing of general controls provisions of the rise, 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 may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Councements concerning your device in the Federal Register.

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Page 2 - Mr. Tom Wang.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r read on 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 or any I odotal batates and states and the best mot limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI I rart 077, mooning (21 CFR Part 820); and if applicable, the electronic forth in the qualisy by by sions (Sections 531-542 of the Act); 21 CFR 1000-1050. product taxall allow you to begin marketing your device as described in your Section 510(k) I ms lotter will and by of substantial equivalence of your device of your device to a legally premated predicated 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 if you dosire specific arrivaliance 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 other golferal micolinines 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,

B/mmumor for

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

KO60077 510(k) Number (if known):

RTT Digital Blood Pressure Monitor Model RTW-8010A Device Name:

Indications For Use:

RTT Digital Blood Pressure Monitor Model RTW-8010A is indicated for nonivasive measurement of systolic and diastolic blood pressure and determination of puslse rate from user's wrist .

Prescription Use (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

B. Bimmima
ision Sign-Off

ion of Cardiovascular Devices

Number

Koo77