RH non-Automated Blood Pressure Meter is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure on children or adults. The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds. There are a variety of stethoscopes can be an optioned accessory. depending on the model.

Device Description

RH non-Automated Blood Pressure Meter is a manual non-invasive aneroid sphygmomanometer which respectively uses an inflation cuff wrapped around the upper arm. The cuff is inflated and deflated by a manual inflation bulb. Besides a manometer (Aneroid gauge), the accessories of MODEL Max02, Max0201, Max0202, Max0203 also includes one selected cuff, one inflation bulb, instruction manual and a vinyl bag. Model Max0202, Max0203 include additional Stethoscope (Single head, Dual head and Sprague Rappaport). It is conjunction with Stethoscope when use.

The PVC or nature latex inflation bulb and optional various size of cuffs which cuffs outside layer is made of Nylon Cloth or Cotton Cloth can be selected according to user's need.

AI/ML Overview

The document provided is a 510(k) Pre-market Notification from the FDA for a non-automated blood pressure meter. It declares substantial equivalence to a predicate device and does not contain specific acceptance criteria, detailed study results, or performance data for the device in question ("RH non-Automated Blood Pressure Meter, MODEL Max02 and RH non-Automated Blood Pressure Meter with Stethoscope, MODEL Max0201, Max0202, Max0203").

Therefore, I cannot provide the requested information. The document explicitly states:

Clinical Study: "No clinical study is included in this submission." (Page 9)
Performance: It mentions that "All performance specification of new devices for various cuff sizes were verified to comply with the ISO81060-1 standard." (Page 9) and "Performance compatible as requirement of ISO 81060-1" (Page 4) but does not provide the actual results or acceptance criteria from these tests. It only lists the accuracy requirement from the standard as "+/- 3 mmHg of reading."

The acceptance criteria and study proving the device meets them are not present in the provided text. The document focuses on demonstrating substantial equivalence to a predicate device, largely through a comparison of general characteristics and adherence to recognized standards, rather than presenting a standalone performance study with detailed acceptance criteria and results.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the word "ADMINISTRATION".

May 22, 2019

Wenzhou Renhua Instruments Co., Ltd Wang Saijie General Manager #.1-1704 Wanda Business Building Yongding Road, Longwan Wenzhou, 325024 CN

Re: K190902

Trade/Device Name: RH non-Automated Blood Pressure Meter, MODEL Max02 and RH non-Automated Blood Pressure Meter with Stethoscope, MODEL Max0201, Max0202, Max0203 Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff

Regulatory Class: Class II Product Code: DXQ, LDE Dated: March 29, 2019 Received: April 8, 2019

Dear Wang Saijie:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for

Matthew Hillebrenner Director (Acting) Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K190902

Device Name

RH non-Automated Blood Pressure Meter, MODEL Max02 and RH non-Automated Blood Pressure Meter with Stethoscope, MODEL Max0201, Max0202, Max0203

Indications for Use (Describe)

RH non-Automated Blood Pressure Meter is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure on children or adults. The device is intended to a patient and manually inflated along with a manual method for detecting Korotkoff sounds. There are a variety of stethoscopes can be an optioned accessory, depending on the model.

Type of Use (Select one or both, as applicable)
Registration Use (Part 1 of CFR 201 Subpart D) One-Time Correction (1 of CFR 201 Subpart C)	Registration Use (Part 1 of CFR 201 Subpart D)	One-Time Correction (1 of CFR 201 Subpart C)
Registration Use (Part 1 of CFR 201 Subpart D)
One-Time Correction (1 of CFR 201 Subpart C)

__ Prescription Use (Part 21 CFR 801 Subpart D)

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

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K190902

Image /page/3/Picture/1 description: The image shows the logo for Wenzhou Renhua Instruments Co., LTD. The logo consists of the letters "RH" in a stylized font, with the company name written in blue text to the right of the letters. The company name is written in all capital letters.

510(k) Summary

Company Name:	WENZHOU RENHUA INSTRUMENTS CO.,LTD
Company Address:	#.1-1704 WANDA BUSINESS BUILDING YONGDING ROAD,LONGWAN ,Wenzhou ,Zhejiang325024 ,CHINA
Telephone:	+86-577-86893308
Fax:	N/A
Contact Person:	WANG SAIJIE
Summary Preparation Date:	2019.3.29
Device Trade Name:	RH non-Automated Blood Pressure Meter, MODEL Max02 and RH non-
	Automated Blood Pressure Meter with Stethoscope, MODEL Max0201,
	Max0202, Max0203
Classification Name:	Blood pressure cuff, Stethoscope, manual
Regulation Number:	21 CFR 870.1120/ 21 CFR 870.1875
Product Code:	DXQ; LDE
Device Class:	Class 2
Panel:	Cardiovascular

PREDICATE DEVICE:

ANEROID SPHYGMOMANOMETER (K173246)

INDICATIONS FOR USE

DEVICE DESCRIPTION

The PVC or nature latex inflation bulb and optional various size of cuffs which cuffs outside layer is

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K190902

made of Nylon Cloth or Cotton Cloth can be selected according to user's need.

Substantial Equivalence Comparison

It is substantially equivalent to the predicate device (K173246), ANEROID SPHYGMOMANOMETER with respect to indications for use, device description, and technical characteristics.

All comparison table for applied devices are as following, and the substantial equivalence determination is based on the 510(k) Substantial Equivalence Decision-Making Process Flowchart which includes the comparison and discussion of indications for use, technology, and performance specifications.

comparison item	New device	Predicate device	Result ofComparasion
Applicant	WENZHOU RENHUAINSTRUMENTS CO.,LTD	Wenzhou BokangInstruments Co., Ltd	Different
	Classification	Class II	Class II	SAME
Regulationnumber	21CFR 870.1120	21CFR 870.1120	SAME
	Product code	DXQ, LDE	DXQ, LDE	SAME
Indications foruse	The device is intended to beused by medicalprofessionals or at home forthe measurement of systolicand diastolic pressure by	The device is intended to beused by medicalprofessionals or at home forthe measurement of systolicand diastolic pressure by	SAME
		RH non-Automated BloodPressure Meter, MODELMax02 and RH non-Automated Blood PressureMeter with Stethoscope,MODEL Max0201,Max0202, Max0203	ANEROIDSPHYGMOMANOMETER,BK2002/BK2002a (K173246)
		comparison item	New device	Predicate device	Result ofComparasion
			RH non-Automated BloodPressure Meter, MODELMax02 and RH non-Automated Blood PressureMeter with Stethoscope,MODEL Max0201,Max0202, Max0203	ANEROIDSPHYGMOMANOMETER,BK2002/BK2002a (K173246)
			detecting Korotkoff sounds.	detecting Korotkoff sounds.
Over-The-Counter Use		Yes	Yes	SAME
Where used		Home, Hospital, healthcarefacility, ambulance etc.	Home, Hospital, healthcarefacility, ambulance etc.	SAME
Target population		infants, children, youngadults and adults	infants, children, youngadults and adults	SAME
Anatomical sites		Upper Arm (leg for child)	Upper Arm (leg for child)	SAME
MeasurementMethod	Auscultatory Korotkoffsounds Method	Auscultatory Korotkoffsounds Method	SAME
Inflation	Manual by inflation bulb	Manual by inflation bulb	SAME
Deflation	Manual deflation via valve	Manual deflation via valve	SAME
Display	Aneroid Manometer	Aneroid Manometer	SAME
The monitor scale	From 0 to 300 mmHg with aminimum interval of 2mmHg.	From 0 to 300 mmHg with aminimum interval of 2mmHg.	SAME
Design of bloodpressure meter	The device comprisestubing attached to a softinelastic cuff with an	The device comprisestubing attached to a softinelastic cuff with an	Same as(BK2002/2002a)
comparison item	New device	Predicate device	Result ofComparasion
	RH non-Automated BloodPressure Meter, MODELMax02 and RH non-Automated Blood PressureMeter with Stethoscope,MODEL Max0201,Max0202, Max0203	ANEROIDSPHYGMOMANOMETER,BK2002/BK2002a (K173246)
	integrated inflatable bladderthat is wrapped around thepatient's limb and securedby hook and loop closure.	integrated inflatable bladderthat is wrapped around thepatient's limb and securedby hook and loop closure.
Design ofStethoscope	Three types option:Single headDual headSprague Rappaport	One type option:Single head	Different
Materials	The manometer: aluminumand stainless steel materials.The tubing, inflation bulb:PVC or nature latex.Cuff: Nylon cloth or cottoncloth for outside layer.Cuff bladder: PVC or naturelatex	The manometer: aluminumand stainless steel materials.The tubing, inflation bulb:PVC or nature latex.Cuff: Nylon cloth or cottoncloth for outside layer.Cuff bladder: PVC or naturelatex	SAME
Accuracy	Pressure:+/- 3 mmHg ofreading	Pressure:+/- 3 mmHg ofreading	SAME
Compatibility	It can be used from 50°F to	It can be used from 50°F to	SAME
comparison item	New deviceRH non-Automated BloodPressure Meter, MODELMax02 and RH non-Automated Blood PressureMeter with Stethoscope,MODEL Max0201,Max0202, Max0203	Predicate deviceANEROIDSPHYGMOMANOMETER,BK2002/BK2002a (K173246)	Result ofComparasion
with environment	104°F (10°C to 40°C) and15% ~ 85%RH humidity.	104°F (10°C to 40°C) and15% ~ 85%RH humidity.
Cuff Size	20"x 5.5" (510mm140mm)21.7" x 6.3"(550mm160mm)24.4" x 6.9"(620mm175mm)28.3" x 8.3"(720mm210mm)13.4" x 4.15"(340mm105mm)10.2" x 3" (260mm75 mm)	20"x 5.5" (510mm140mm)21.7" x 6.3"(550mm160mm)24.4" x 6.9"(620mm175mm)28.3" x 8.3"(720mm210mm)13.4" x 4.15"(340mm105mm)10.2" x 3" (260mm75 mm)	SAME
CuffCircumference	Fits arm circumferences8.7" to 17.3" (220mm to440 mm), The standard cuffshould be available for usein measuring a child's legblood pressure and forchildren with larger arms.	Fits arm circumferences8.7" to 17.3" (220mm to440 mm), The standard cuffshould be available for usein measuring a child's legblood pressure and forchildren with larger arms.	SAME
Cuff bladder Size	8.7"x 4.7"(220mm120mm)11.8"x5.9"(300mm150mm)13.4"x6.7"(340mm170mm)6.9"x 3.3"(175mm85mm)	8.7"x 4.7"(220mm120mm)11.8"x5.9"(300mm150mm)13.4"x6.7"(340mm170mm)6.9"x 3.3"(175mm85mm)	SAME
comparison item	New device	Predicate device	Result ofComparasion
	RH non-Automated BloodPressure Meter, MODELMax02 and RH non-Automated Blood PressureMeter with Stethoscope,MODEL Max0201,Max0202, Max0203	ANEROIDSPHYGMOMANOMETER,BK2002/BK2002a (K173246)
	7.5"x 2"(190mm*50mm)	7.5"x 2"(190mm*50mm)
Cuff Color	Blue, Pink, Black	Blue, Gray, Red, Green,Pink,Yellow, Black	Different
Contents (withaccessories)	Aneroid gauge, Arm Cuff,Inflation Bulb, Vinyl storagepouch and InstructionManual, Stethoscope(option)	Aneroid gauge, Arm Cuff,Inflation Bulb, Vinyl storagepouch and InstructionManual, Stethoscope(option)	Same
Biocompatibility	biocompatible asrequirement of ISO 10993-1ISO 10993-5ISO 10993-10	biocompatible asrequirement of ISO 10993-1ISO 10993-5ISO 10993-10	Same modeland samesupplier
Performance	compatible as requirementof ISO 81060-1	compatible as requirementof ISO 81060-1	Same

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Image /page/5/Picture/1 description: The image shows a stylized logo with the letters 'Rh' in a cursive font. The letters are light blue and have a subtle gradient effect, with a slightly darker shade at the bottom. There is a soft drop shadow behind the letters, giving them a three-dimensional appearance against the white background.

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Image /page/6/Picture/1 description: The image shows the letters "RH" in a stylized font. The letters are in a gradient of light blue, with a darker blue shadow effect. The letters are slightly curved and connected, giving them a flowing appearance. The background is plain white.

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Image /page/7/Picture/1 description: The image shows a stylized logo with the letters 'RH' in a cursive font. The letters are rendered in a gradient of light blue, giving them a three-dimensional appearance. The logo is simple and elegant, with a clean design.

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Image /page/8/Picture/1 description: The image shows a stylized logo with the letters 'Rh' in a cursive font. The letters are light blue and have a subtle gradient effect, with a slightly darker shade at the bottom. There is a soft drop shadow behind the letters, giving them a three-dimensional appearance against the white background.

Discussion

Comparing with the predicate device, ANEROID SPHYGMOMANOMETER (K173246), RH non-Automated Blood Pressure Meter, MODEL Max02 and RH non-Automated Blood Pressure Meter with Stethoscope, MODEL Max0201, Max0202, Max0203 have same product name, classification and product code, product physical design and operation, same Aneroid gauge, packaging materials, performance parameter ranges, physical properties, mechanical properties, the subject cuffs are the same like our own cleared under predicate K173426 and that the biocompatibility standards compliance/reports are the same. The differences between those two devices are as following,

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K190902

Image /page/9/Picture/1 description: The image contains the logo for Wenzhou Renhua Instruments Co., LTD. The logo features a stylized, cursive "RH" in a light blue gradient. To the right of the logo, the company name is written in blue, with "WENZHOU RENHUA INSTRUMENTS CO.,LTD" on a single line.

Comparing the predicate device ANEROID SPHYGMOMANOMETER (K173246), the design of new device is same as BK2002/BK2002a except there are no Gray, Red, Green and yellow cuff color included.
Design of Stethoscope for new device, there are added the combination of "Dual head" Stethoscope (Max0202) and "Sprague Rappaport" Stethoscope (Max0203). The different type of Stethoscopes didn't raise any safety or effectiveness issue.
All performance specification of new devices for various cuff sizes were verified to comply with the ISO81060-1 standard. (Please see section 18 of this submission)

Non-Clinical Testing

Non-clinical testing included biocompatibility and bench testing. The tests listed in the ISO10993 and ISO81060-1, were included. Results of testing were acceptable.

Clinical Study

No clinical study is included in this submission.

CONCLUSION

RH non-Automated Blood Pressure Meter, MODEL Max02 and RH non-Automated Blood Pressure Meter with Stethoscope, MODEL Max0201, Max0202, Max0203 have the same intended use and similar technological characteristics as the above predicate devices. Moreover, information contained in this submission supplied demonstrates that any differences in their characteristics do not raise any new questions of safety or effectiveness. Thus, RH non-Automated Blood Pressure Meter, MODEL Max02 and RH non-Automated Blood Pressure Meter with Stethoscope, MODEL Max0201, Max0202, Max0203 are substantially equivalent to the predicate devices.

Regulation Number and Section

§ 870.1120 Blood pressure cuff.

(a)
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.(b)
Classification. Class II (performance standards).