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510(k) Data Aggregation
K Number
K243003Device Name
VitalSigns 1-Lead Holter (VSH101)
Manufacturer
VitalSigns Technology Co., Ltd.
Date Cleared
2025-06-17
(264 days)
Product Code
DXH
Regulation Number
870.2920Why did this record match?
Applicant Name (Manufacturer) :
VitalSigns Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VSH101 is designed to record, transmit, and store single channel electrocardiogram (ECG) data via Bluetooth communication to compatible Bluetooth enabled devices. The device is intended for use by healthcare professionals, individuals with known or suspected cardiac conditions, and health-conscious users. The ECG data serves as a supplementary source of patient information and is not intended for automated analysis.
Device Description
VitalSigns 1-Lead Holter is an ambulatory and Bluetooth-based wireless communication ECG measurement solution designed to allow users to record, store, transmit, and display single-channel ECG data.
VitalSigns 1-Lead Holter consists of the following three components:
1. VS Electrode Patch "VSP101"
2. ECG Recorder Host "VSH101"
3. iOS APP "VSHealth"
When the ECG Recorder Host "VSH101" is fully charged and connected wirelessly via Bluetooth to the iOS app "VSHealth", it can instantly obtain the user's ECG data. VSHealth assists in transmitting, displaying, recording, and storing ECG data.
After the "VSH101" is fully charged, the device, through the VSHealth app, allows users to continuously use and record ECG data for 24 hours in their daily routines, whether at home or in a work environment.
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