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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 a medical device manufactured by Lotusnine Medical Limited. It received FDA 510(k) clearance on 2022-01-27 under approval 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. It is manufactured by Lotusnine Medical Limited. The 510(k) number is K212312.

When was RA-T59 Wrist blood pressure monitor approved by the FDA?

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

What company makes RA-T59 Wrist blood pressure monitor?

RA-T59 Wrist blood pressure monitor is manufactured by Lotusnine Medical Limited.

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

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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: 41623865 Case Report: Hypertensive encephalopathy presents with complex types of sleep breathing events. Frontiers in cardiovascular medicine (2025)

Related Devices (Code: DXN)

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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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