Skip to content

Healthtracker

by Wistron Corporation

510(k) K110770

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 NumberK110770 Date16 Nov 2011ClearedStatusActive

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  • Withdrawn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, 19 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 Healthtracker is a cardiovascular monitoring device, classified under product code DXN, designed for tracking and assessing physiological parameters related to heart function. It is intended for use in clinical settings to provide real-time data on cardiac activity, aiding in patient evaluation and diagnostic processes.

This device is supplied as a reusable medical instrument and is regulated under FDA 510(k) clearance (K110770), with a decision date of November 16, 2011. It is manufactured by Wistron Corporation and falls under the Cardiovascular advisory committee review. No specific sterility or MRI safety information is provided in the available data.

Other devices from Wistron Corporation