VitalSigns 1-Lead Holter (VSH101)
VitalSigns Technology Co., Ltd.The VitalSigns 1-Lead Holter (VSH101) is a wireless, ambulatory ECG monitoring device that records, transmits, and stores single-channel ECG data via Bluetooth to a compatible mobile app. It helps healthcare professionals and individuals with cardiac conditions by providing supplementary ECG information for patient monitoring.
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.
Technology
The device includes a VS Electrode Patch, ECG Recorder Host (VSH101), and an iOS app (VSHealth). It uses Bluetooth wireless communication to transmit ECG data from the device to the app, enabling continuous ambulatory ECG recording for 24 hours. The electrode patch uses medical-grade nonwoven tape and sensing hydrogels to ensure stable conductivity and biocompatibility.
Performance
The device passed all non-clinical performance testing including biocompatibility, electrical safety, electromagnetic compatibility, lithium battery safety, and software validation. Testing was performed per applicable IEC standards and USFDA guidance, confirming safety and substantial equivalence to predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/26/2024
8 months - 2
FDA Approval
6/17/2025
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