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FDA 510(k)

Wrist-type Fully Automatic Digital Blood Pressure Monitor

K-Number: K213189 · 2022-03-01

ApplicantJoytech Healthcare Co. , Ltd.
Decision Date2022-03-01
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Wrist-type Fully Automatic Digital Blood Pressure Monitor is a medical device manufactured by Joytech Healthcare Co. , Ltd.. It received FDA 510(k) clearance on 2022-03-01 under approval number K213189. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Wrist-type Fully Automatic Digital Blood Pressure Monitor?

Wrist-type Fully Automatic Digital Blood Pressure Monitor is a medical device that received FDA 510(k) clearance on 2022-03-01. It is manufactured by Joytech Healthcare Co. , Ltd.. The 510(k) number is K213189.

When was Wrist-type Fully Automatic Digital Blood Pressure Monitor approved by the FDA?

Wrist-type Fully Automatic Digital Blood Pressure Monitor received FDA 510(k) clearance on 2022-03-01, under approval number K213189.

What company makes Wrist-type Fully Automatic Digital Blood Pressure Monitor?

Wrist-type Fully Automatic Digital Blood Pressure Monitor is manufactured by Joytech Healthcare Co. , Ltd..

What is the FDA product code for Wrist-type Fully Automatic Digital Blood Pressure Monitor?

The FDA product code for Wrist-type Fully Automatic Digital Blood Pressure Monitor is DXN.

Related Clinical Trials

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Related PubMed Literature

PMID: 41836285 A Case Study of AI-Enabled Software as a Medical Device Cleared by the FDA for Assessing Hemorrhage Risk Index (APPRAISE-HRI) after Trauma. NEJM AI (2025) PMID: 40388896 Accuracy and Safety of a Continuous Noninvasive Blood Pressure Monitor in Neonates. Neonatology (2025) PMID: 39670276 Multicenter Evaluation of Machine-Learning Continuous Pulse Rate Algorithm on Wrist-Worn Device. Digital biomarkers (2024) PMID: 28216355 Innovative postmarket device evaluation using a quality registry to monitor thoracic endovascular aortic repair in the treatment of aortic dissection. Journal of vascular surgery (2017)

Other Devices by Joytech Healthcare Co. , Ltd.

K172989Electric Breast Pump K170666The Wrist-Type Fully Automatic Digital Blood Pressure Monitors K163518Digital Thermometer K181239Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer K181081Infrared Ear Thermometer K173024Non-invasive blood pressure measurement systems

View all 22 devices →

Related Devices (Code: DXN)

K162092Evolv Model BP7000 Upper Arm Blood Pressure MonitorOmron Healthcare, Inc. K161708Arm automatic blood pressure monitorShenzhen Pump Medical System Co., Ltd. K162230Fully Automatic Electronic Blood Pressure MonitorAdon Health Co., Ltd. K160349Electronic SphygmomanometerGuangdong Biolight Meditech Co., Ltd. K161846Automatic Arm Bluetooth Blood Pressure MonitorTruly Instrument Limited K161886Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure DeviceGuangdong Transtek Medical Electronics Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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