Who is the manufacturer of TRANSTEK BLOOD PRESSURE MONITOR MODEL TMB-986, TMB-987, TMB-995?

Zhongshan Transtek Electronics Co., Ltd. filed the 510(k) submission for TRANSTEK BLOOD PRESSURE MONITOR MODEL TMB-986, TMB-987, TMB-995 (K101681).

What is the FDA product code for TRANSTEK BLOOD PRESSURE MONITOR MODEL TMB-986, TMB-987, TMB-995?

DXN. It is classified under 21 CFR 870.1130 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for TRANSTEK BLOOD PRESSURE MONITOR MODEL TMB-986, TMB-987, TMB-995?

510(k) clearance (submission type: Abbreviated).

Who can help prepare an FDA 510(k) submission like TRANSTEK BLOOD PRESSURE MONITOR MODEL TMB-986, TMB-987, TMB-995?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

TRANSTEK BLOOD PRESSURE MONITOR MODEL TMB-986, TMB-987, TMB-995

K101681 · Zhongshan Transtek Electronics Co., Ltd. · DXN · May 27, 2011 · Cardiovascular

Device Facts

Record ID	K101681
Device Name	TRANSTEK BLOOD PRESSURE MONITOR MODEL TMB-986, TMB-987, TMB-995
Applicant	Zhongshan Transtek Electronics Co., Ltd.
Product Code	DXN · Cardiovascular
Decision Date	May 27, 2011
Decision	SESE
Submission Type	Abbreviated
Regulation	21 CFR 870.1130
Device Class	Class 2

Intended Use

Transtek Blood Pressure Monitor, Models TMB 986, TMB987, and TMB995 are digital monitors intended for use in measuring blood pressure and heartbeat rate in adult patient population with arm circumference ranging from 22 cm to 42 cm (about 9 - 17 inches). These devices detect the appearance of irregular heartbeats during measurement and give a warning signal with readings. The Blood Pressure Monitor compares average blood pressure results to pre-established AHA (American Heart Association) hypertension guideline of 135/85 mmHg. Transtek Blood Pressure Monitor, TMB-986, TMB-987, and TMB-995 models are not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.

Device Story

Digital oscillometric blood pressure monitor; measures systolic/diastolic pressure and heart rate via inflatable arm cuff. Input: cuff pressure oscillations detected by electronic sensor. Processing: microprocessor analyzes pressure signals to derive blood pressure/heart rate; compares pulse wave intervals to detect irregular heartbeats (threshold >25% difference). Output: LCD displays readings and irregular heartbeat warning; compares results to AHA 135/85 mmHg guideline. Used in home/clinical settings by patients or clinicians. Powered by batteries or AC adapter. Provides non-diagnostic monitoring; alerts users to consult physicians for hypertensive readings.

Clinical Evidence

Bench testing only. Performance verified through biocompatibility, electromagnetic compatibility, and electrical safety testing. Accuracy validated against standard oscillometric requirements.

Technological Characteristics

Oscillometric measurement principle; electronic pressure sensor; microprocessor-controlled. ABS plastic housing; nylon cuff with inflatable bladder. Powered by 4x AAA/AA batteries or 6V DC adapter. Digital LCD display. Continuous operation mode. No wireless connectivity.

Indications for Use

Indicated for adult patients with arm circumferences 22-42 cm for non-invasive measurement of systolic/diastolic blood pressure and heart rate. Includes irregular heartbeat detection. Not for diagnostic use.

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.

Predicate Devices

OMRON, Automatic Blood Pressure Monitor, Model HEM 780N3 (K061822)

Related Devices

K061822 — OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH COMFIT CUFF, MODEL HEM 780 N3 · Omron Healthcare, Inc. · Aug 2, 2006
K210671 — Digital Blood Pressure Monitor WBP Series, including: WBP101, WBP102, WBP103, WBP104, WBP105, WBP106, WBP107 · Weony (Shenzhen) Technology Co., Ltd. · Aug 13, 2021
K080289 — 1500 PRO · Omron Healthcare, Inc. · Feb 26, 2008
K091434 — TRULY AUTOMATIC ARM BLOOD PRESSURE MONITORDB21,DB31,DB22,DB23,DB71M,DB32,DB61M, DB62M, DB63M · Truly Instrument Co., Ltd. · Sep 4, 2009
K110330 — FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR · Andon Health Co, Ltd. · Feb 18, 2011

Submission Summary (Full Text)

{0}------------------------------------------------ TRANSTEK # Section 5 - 510(k) Summary Date of Summary Preparation: 11/09/2010 #### 1. Submitter's Identifications Submitter's Name: ZHONGSHAN TRANSTEK ELECTRONIC CO., LTD. Address: Jinbiao Road, Minzhong, Zhongshan City, Guangdong, China Contact Person: Guo Zhiping Contact Email Address: gzp@transtek.cn Telephone: 086-760-88282982 ext. 231 Fax: 086-760-85339231 #### 2. Correspondent's Identifications Correspondent's Name: A03 Lab of BTS Address: No.1 Fanghua Street, Hi-tech Zone, Chengdu City, Sichuan, China Contact Person: Leo Wang Contact Email Address: leo.w(@hibts.com Telephone: 086-28-86083300 Fax: 086-4006070050 ext. 8 #### 3. Name of the Device Device Classification Name: System, Measurement, Blood-Pressure, Non-invasive Product Name: Blood Pressure Monitor Trade Name: Transtek Models: TMB-986, TMB-987, TMB-995 Classification Panel: Cardiovascular Common/Usual Name: Automatic Blood Pressure Monitor Product Code: DXN Device Classification: Class II Contraindications: None #### 4. The Predicate Devices OMRON, Automatic Blood Pressure Monitor, Model HEM 780N3, K061822 #### 5. Device Description Transtek Blood Pressure Monitor, TMB-986, TMB-987, and TMB-995 are designed to measure the systolic and diastolic blood pressure and heartbeat rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the arm. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses ### MAY 2 7 2011 {1}------------------------------------------------ # TRANSTE an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating heartbeat rate, which is a well-known technique in the market called the "Oscillometric method". Transtek Blood Pressure Monitor is single-mounted devices of the main unit and cuff unit. ABS is used to outer housing of the main unit. The preformed cuff unit, which is applicable to arm circumference approximately between 22 and 42 cm, includes the inflatable bladder and nylon shell. All models of the arm blood pressure monitor can use the same two size of cuff (22 - 32cm, or 22 - 42cm). Product package will contains only one cuff and which size is decide by business requirement. The device consists of the microprocessor, the pressure sensor, the operation keys, the pump, the electromagnetic deflation control valve and the LCD. The subject devices are powered by four AAA or AA alkaline batteries or by a DC 6V 400mA adapter. I The device also compares the longest and the shortest time intervals of detected pulse waves to mean time interval and displays a warning signal with the reading to indicate the detection of irregular heartbeat when the difference of the time intervals is over 25%. #### 6. Intended Use of Device Transtek Blood Pressure Monitor, Models TMB 986, TMB987, and TMB995 are digital monitors intended for use in measuring blood pressure and heartbeat rate in adult patient population with arm circumference ranging from 22 cm to 42 cm (about 9 - 17 inches). These devices detect the appearance of irregular heartbeats during measurement and give a warning signal with readings. The Blood Pressure Monitor compares average blood pressure results to pre-established AHA (American Heart Association) hypertension guideline of 135/85 mmHg. Transtek Blood Pressure Monitor, TMB-986, TMB-987, and TMB-995 models are not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated. #### 7. Summary of Substantial Equivalence Table 1: The difference between Transtek Blood Pressure Monitor | | The Similarities and Difference among TMB-986, TMB-987 and TMB-995 | | | | | | |----|--------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|--| | | Feature | TMB-986 | TMB-987 | TMB-995 | Comparison | | | 1 | Power supply | Battery powered mode: | | | | | | | | 6VDC 4*AAA alkaline batteries | 6VDC 4*AAA alkaline batteries | 6VDC 4*AA alkaline batteries | similar | | | | | AC adaptor powered mode: | | | | | | | | AC 100-240V, 50-60Hz, 400mA | AC 100-240V, 50-60Hz, 400mA | AC 100-240V, 50-60Hz, 400mA | similar | | | | Feature | TMB-986 | TMB-987 | TMB-995 | Comparison | | | 2 | Display mode | Digital LCD V.A.128*50mm | Digital LCD V.A.150*34mm | Digital LCD V.A.128*50mm | TMB-986, and TMB-995: 128*50mm TMB-987: 150*34mm | | | 3 | Measurement mode | Oscillographic testing mode | Oscillographic testing mode | Oscillographic testing mode | similar | | | 4 | Accuracy | Pressure: $15℃~25℃$ : within±0.4kpa / 3mmHg $10℃~40℃$ (out of $15℃~25℃$ ): Within ±0.65kpa / 5mmHg Heartbeat: value:±5% | Pressure: $15℃~25℃$ : within±0.4kpa / 3mmHg $10℃~40℃$ (out of $15℃~25℃$ ): Within ±0.65kpa / 5mmHg Heartbeat: value:±5% | Pressure: $15℃~25℃$ : within±0.4kpa / 3mmHg $10℃~40℃$ (out of $15℃~25℃$ ): Within ±0.65kpa / 5mmHg Heartbeat: value:±5% | similar | | | 5 | Normal working condition | Temperature: $10℃$ $~40℃$ Relative humidity ≤80% | Temperature: $10℃$ $~40℃$ Relative humidity ≤80% Barometric pressure: 105~80 kPa (790~600 mmHg) | Temperature: $10℃$ $~40℃$ Relative humidity ≤80% | similar | | | 6 | Storage & transportation condition | Temperature: - $20℃~60℃$ | | | | | | | | Relative humidity:10~93% | Relative humidity: 10~93% | Relative humidity:10~93% | similar | | | 7 | Measurement perimeter of upper arm | 22cm~42cm | 22cm~42cm | 22cm~42cm | similar | | | 8 | Weight | Approx.300g (Excluding the batteries) | Approx.300g (Excluding the batteries) | Approx.300g (Excluding the batteries) | similar | | | 9 | External dimensions | Approx. 180*100*39mm | Approx. 200*60*56mm | Approx. 180*100*39mm | TMB-986, and TMB-995: Approx. 180*100*39mm TMB-987: Approx. 200*60*56mm | | | 10 | Mode of operation | Continuous operation | Continuous operation | Continuous operation | similar | | ર-2 {2}------------------------------------------------ # TRANSTEK 北 5-3 {3}------------------------------------------------ TRANSTEK | Feature | TMB-986, TMB-987, TMB-995 | Predicate: HEM 780N3 | Comparison | |------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------| | Device name | Blood Pressure Monitor | Automatic Blood Pressure Monitor | Similar | | Indication for use | Measure the blood pressure and heartbeat rate. Irregular heartbeat detection. | Measure the blood pressure and heartbeat rate. | Add new features | | Components | Main Unit, Cuff, Adapter, Instruction Manual, 4*AAA /4*AA batteries, Storage Case and Warranty Card | Main Unit, Cuff, Adapter, Instruction Manual, 4"AA"batteries, Storage Case and Warranty Card | Similar components and materials | | Performance Tests | Biocompatibility Electromagnetic Compatibility and Electrical Safety | Biocompatibility Electromagnetic Compatibility and Electrical Safety | Similar | | Labeling | Company name and address Specification Product description Indication for use Contraindications for use Precautions Warnings Safety terms and conditions Safety alert descriptions Safety and performance standards and so on | Company name and address Specification Product description Indication for use Contraindications for use Precautions Warnings Safety terms and conditions Safety alert descriptions Safety and performance standards and so on | Similar | | Energy used | Battery (4*AAA/4*AA) or AC adapter (DC 6V Output) | Battery (4*AA) or AC adapter (DC 6V Output) | Similar | | Display | Liquid crystal digital display | Liquid crystal digital display | Similar | | Dimensions | TMB-986, TMB-995: 180(W)*100(D)*39(H)mm TMB-987: 200(W)*60(D)*56(H)mm | 131(W)*155(D)*85(H)mm | Similar | | Applicable cuff | Wrap around cuff | Wrap around cuff | Similar | | Accuracy of pressure indicator | Within ±3mmHg(15~25℃) Within ±5mmHg (10°C~40°C(out of 15℃~25℃)) | Within ±3mmHg or 2% of reading | Similar | | Accuracy of heartbeat rate | Within ±5% of reading | Within ±5% of reading | Similar | | Feature | TMB-986, TMB-987, TMB-995 | Predicate: HEM 780N3 | Comparison | | Cuff inflation | Automatic inflation with air pump | Automatic inflation with air pump | Similar | | Deflation of pressure | Automatic air release | Deflation rate is controlled by an active electronic control valve by 4 to 11 mmHg/s depending on pulse rate | Similar | | Operating voltage | DC 6V | DC 6V | Similar | | Measurement perimeter of upper arm | 22cm~42cm | 22cm~42cm | Similar | | Operation environment | Temperature: 10℃~40℃ Relative humidity: ≤80% Barometric pressure: 105~80 kPa (790-600 mmHg) | Temperature: 10℃~40℃ Relative humidity: 30-80% Barometric pressure: 105~80 kPa (790-600 mmHg) | Similar | | Transport and storage environment | Temperature: -20℃~60℃ Relative humidity:10~93% | Temperature: -20℃~60℃ Relative humidity: 10~95% | Similar | Table 2: The difference between Transtek Blood Pressure Monitor and Predicate HEM 780N3 4/5 {4}------------------------------------------------ S/C #### 8. Conclusions The subject devices have all features of the predicate device HEM 780N3 except the new features of irregular heartbeat detection, some specification of arm cuff and battery. These differences do not affect the safety and effectiveness of the subject devices. Irregular heartbeat detection technology is same as what is used in Automatic Blood Pressure Monitor with Com Fit™ Cuff Model HEM-780. Thus, the subject devices are substantially equivalent to the predicate device. --- End of this section -- {5}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized bird-like symbol with three curved lines forming the body and wings. Below the bird, there are wavy lines that represent water. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Zhongshan Transtek Electronic Co., Ltd. c/o Mr. Leo Wang A03 Lab of BTS No. 1 Fanghua Street, Hi-tech District Chengdu City, Sichuan CHINA MAY 2 7 2011 Re: K101681 Trade/Device Name: Transtek Blood Pressure Monitor Models TMB-986, TMB-987 and TMB-995 Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Monitoring System Regulatory Class: Class II (Two) Product Code: DXN Dated: Undated Received: May 13, 2011 Dear Mr. Wang: 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 10 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 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. {6}------------------------------------------------ Page 2 – Mr. Leo Wang 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fdagov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, D. Zahariev, M.D. Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ # TRANSTEK # Section 4 - Indications for Use 510(k) Number (if known): K101681 Device Name: Blood Pressure Monitor Models: TMB-986, TMB-987, TMB-995 Indications for Use: This series of devices are digital monitors intended for use in measuring blood pressure and heartbeat rate in adult patient population with arm circumference ranging from 22 cm to 42 cm (about 9 - 17 inches). These devices detect the appearance of irregular heartbeats during measurement and give a warning signal with readings. The Blood Pressure Monitor compares average blood pressure results to pre-established AHA (American Heart Association) hypertension guideline of 135/85 mmHg. Transtek Blood Pressure Monitor, TMB-986, TMB-987, and TMB-995 models are not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated. Prescription Use AND/OR (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) メ (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | Concurrence of CDRH, Office of Device Evaluation (ODE) | | |--------------------------------------------------------|--| | (Division Sign-Off) | | | Division of Cardiovascular Devices | | | 510(k) Number | | 11/0168