Device Information:
The Digital Blood Pressure Monitor Model BM 92 is non-invasive and uses an oscillometric method to measure blood pressure and pulse rate. It features an arm cuff and an electric pump for inflation, with a rapid deflation valve. The device measures pressures up to 299 mmHg and pulse rates from 30 to 180 beats per minute. It also includes Bluetooth for transmitting data to an app. The device stores up to 240 measurements and provides irregular heartbeat detection.
Indications:
The device measures blood pressure (systolic and diastolic) and pulse rate for adults and adolescents over 12 years of age. It is suitable for arm circumferences between 22 and 42 cm. It is recommended for home or clinical use.
Intended Use of Digital Blood Pressure Monitor Model BM 92
This device is intended for measuring systolic and diastolic blood pressure and pulse rate in adults and adolescents over 12 years. It can be used by both individuals and healthcare professionals.
Availability:
This device is available over-the-counter (OTC).
Study Results:
Clinical Testing:
Clinical testing followed ISO 81060-2 standards. Ninety patients participated, and the study confirmed that the device’s measurements met accuracy requirements without adverse effects.
Nonclinical Testing:
The Digital Blood Pressure Monitor Model BM 92 underwent safety and performance tests according to IEC standards, including electrical safety, biocompatibility, and electromagnetic compatibility. The Bluetooth feature was also tested.
Regulatory Information:
- Regulation Number: 21 CFR 870.1130
- Regulatory Class: Class II
- Product Code: DXN
- 510(k) Number: K231303
- The device complies with regulations for non-invasive blood pressure monitors under 21 CFR 870.1130 and must adhere to the FDA’s quality and safety standards.
Manufacturer Information:
- Name: Joytech Healthcare Co., Ltd
- Address: No. 365, Wuzhou Road, Yuhang Economic Development Zone, Hangzhou, Zhejiang 311100, China
- Contact Person: Yunhua Ren
Predicate Device Information:
- Primary Predicate Device: Globalcare GUS622 Blood Pressure Monitor (K192609)
- The predicate device and the BM 92 share similar technological characteristics, though the BM 92 includes Bluetooth functionality. Both devices use the same method for measuring blood pressure and pulse.
Implications:
This device offers users a reliable, convenient way to monitor blood pressure and pulse at home or in a clinical setting. Its Bluetooth function allows seamless tracking of health data.
References:
- Arm-type Fully Automatic Digital Blood Pressure Monitor. 510(k) Number: K231303. Joytech Healthcare Co., Ltd: FDA summary Link https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K231303
- https://www.sejoy.com.
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