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Ezsleep Sleep Quality Recorder

by Platinum Team Co., Ltd.

510(k) K112573

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 NumberK112573 Date22 Mar 2012ClearedStatusActive

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  • Withdrawn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
MWJ
Device Class
Class II
Regulation
21 CFR Part 870.2800
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 Ezsleep Sleep Quality Recorder is an ambulatory electrocardiograph device designed for heart rate recording. It functions as a small, battery-powered unit that operates without analysis.

This device is regulated as a Class 2 cardiovascular device under 21 CFR 870.2800 and has received FDA 510(k) clearance. It is identified by product code MWJ and reference number K112573.

Questions

AI-generated answers, 24 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 primary function of the Ezsleep Sleep Quality Recorder?

    The Ezsleep Sleep Quality Recorder is an ambulatory electrocardiograph device specifically designed for heart rate recording. It functions as a compact, battery-powered unit that captures data without performing internal analysis.

  • How is this device classified for regulatory purposes?

    This device is regulated as a Class 2 cardiovascular device under 21 CFR 870.2800. It has received FDA 510(k) clearance, identified by product code MWJ and reference number K112573.

  • What is the regulatory status of the Ezsleep Sleep Quality Recorder?

    The device has received FDA 510(k) clearance. This indicates that the device has been reviewed and found to be substantially equivalent to other legally marketed devices within the cardiovascular medical specialty.