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Hexoskin Medical System (7100-00016)

by Carre Technologies, Inc.

510(k) K243981

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 NumberK243981 Date18 Nov 2025ClearedStatusActive

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  • Withdrawn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
DXH
Device Class
Class II
Regulation
21 CFR Part 870.2920
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Hexoskin Medical System is a Class 2 medical device classified as a transmitter/receiver and electrocardiograph. It records, displays and stores three‑lead electrocardiogram signals together with heart rate, respiratory rate and activity data for cardiovascular monitoring.

The system is intended for use at home or in a healthcare facility under the order of a licensed medical professional. It is supplied as a complete system, identified by model number 7100-00016, and has received FDA 510(k) clearance (K243981) with product code DXH.

Questions

AI-generated answers, 25 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 Hexoskin Medical System used for?

    The Hexoskin Medical System records, displays and stores three-lead electrocardiogram signals along with heart rate, respiratory rate and activity data to support cardiovascular monitoring in patients at home or in healthcare facilities under the direction of a licensed medical professional.

  • How is the Hexoskin Medical System supplied and identified?

    The system is supplied as a complete unit identified by model number 7100-00016 and includes the necessary components to record and transmit ECG, heart rate, respiratory rate and activity data for monitoring purposes.

  • Is the Hexoskin Medical System intended for single-use or reuse?

    The device data does not specify whether the Hexoskin Medical System is single-use or reusable; however, as a transmitter/receiver and electrocardiograph designed for ongoing monitoring, it is intended for repeated use under professional supervision, with components such as sensors or garments potentially subject to separate use limitations not detailed in the provided information.