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RA-T59 Wrist blood pressure monitor

by Lotusnine Medical Limited

510(k) K212312

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK212312 Date27 Jan 2022ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DXN
Device Class
Class II
Regulation
21 CFR Part 870.1130
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The RA-T59 Wrist blood pressure monitor is a device designed to measure blood pressure at the wrist. It is intended for use in monitoring cardiovascular parameters as part of routine health assessment.

The device is supplied as a non-sterile, reusable unit for use in home or clinical settings. It has received FDA 510(k) clearance under product code DXN and is classified as substantially equivalent to a predicate device. No claims regarding sterility, single-use status, MRI safety, or specific storage conditions are provided in the data.

Questions

AI-generated answers, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the RA-T59 Wrist blood pressure monitor used for?

    The RA-T59 Wrist blood pressure monitor is designed to measure blood pressure at the wrist and is intended for monitoring cardiovascular parameters as part of routine health assessment in home or clinical settings.

  • Is the RA-T59 Wrist blood pressure monitor sterile or single-use?

    The RA-T59 is supplied as a non-sterile, reusable unit. It is not designed for single-use and can be used multiple times in appropriate settings.

  • What regulatory approvals does the RA-T59 Wrist blood pressure monitor have?

    The RA-T59 has received FDA 510(k) clearance under product code DXN and is classified as substantially equivalent to a predicate device. It was reviewed by the Cardiovascular advisory committee.

  • What are the specifications of the RA-T59 Wrist blood pressure monitor?

    The RA-T59 is a wrist blood pressure monitor with no specific measurements provided in the data. It is a reusable device for blood pressure measurement and cardiovascular parameter monitoring.