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FDA 510(k)

RA-T59 Wrist blood pressure monitor

K-Number: K212312 · 2022-01-27

ApplicantLotusnine Medical Limited
Decision Date2022-01-27
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RA-T59 Wrist blood pressure monitor is the device name listed in this FDA 510(k) record. The listed applicant is Lotusnine Medical Limited. It received FDA 510(k) clearance on 2022-01-27 under 510(k) number K212312. 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 RA-T59 Wrist blood pressure monitor?

RA-T59 Wrist blood pressure monitor is a medical device that received FDA 510(k) clearance on 2022-01-27. The listed applicant is Lotusnine Medical Limited. The 510(k) number is K212312.

When did RA-T59 Wrist blood pressure monitor receive FDA 510(k) clearance?

RA-T59 Wrist blood pressure monitor received FDA 510(k) clearance on 2022-01-27, under 510(k) number K212312.

Who is the listed applicant for RA-T59 Wrist blood pressure monitor?

The FDA 510(k) record lists Lotusnine Medical Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RA-T59 Wrist blood pressure monitor?

The FDA product code for RA-T59 Wrist blood pressure monitor is DXN.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07633886Multi-Centre Based Evaluation of the Performance and Safety of the Corsano CardioWatch 287-2 Blood Pressure Monitoring Device at Wrist Against BP-Cuff Measurements (COR-BP)NOT_YET_RECRUITINGNCT07713576Clinical Trial of Wrist Ambulatory Blood Pressure Monitor in Conformance With the ISO 81060-2:2018+AMD1:2020+AMD2:2024.COMPLETED

Related Devices (Code: DXN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261061BP Go (BPP-855)Wellvii, Inc.K253425Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P)Joytech Healthcare Co. , Ltd.K261136Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)Guangzhou Daxin Health Technology Co., Ltd.K261082Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)Microlife CorporationK253126Wrist Blood Pressure Monitor (XW-05)Shenzhen Ziqing Medical Equipment Co., Ltd.K260693VicorderCS (VCS-SYS-1100)80 Beats Medical GmbH

Official Source

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

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