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510(k) K151835

Vital Signs Patch System by Lifewatch Technologies , Ltd. — Product Code DSI

K151835 is an FDA 510(k) premarket notification submitted by Lifewatch Technologies , Ltd. for the device "Vital Signs Patch System". The FDA issued a decision of Substantially Equivalent on February 5, 2016. The device falls under product code DSI (Detector And Alarm, Arrhythmia), a Class II device regulated under 21 CFR 870.1025. Lifewatch Technologies , Ltd. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 2016
Date Received
July 6, 2015
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Detector And Alarm, Arrhythmia
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type

Other clearances by Lifewatch Technologies , Ltd.

  • K151269 — ECG Mini System Continuous ECG Monitor and Arrhythmia Detector (January 15, 2016)
  • K143359 — CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector (September 11, 2015)
  • K132407 — VITAL SIGNS PATCH SYSTEM (IN SHORT VSP) (December 19, 2014)

Other clearances for product code DSI

  • K243349 — BodyGuardian Remote Monitoring System (BGRMS v3.0) (January 23, 2026)
  • K250356 — MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000) (July 29, 2025)
  • K240177 — Zio AT® device (A100A1001) (October 30, 2024)
  • K230265 — MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System (October 6, 2023)
  • K231276 — SmartCardia 7L Platform (August 30, 2023)
  • K193104 — Unified Arrhythmia Diagnostic System PocketECG IV (April 9, 2020)
  • K192732 — BodyGuardian Remote Monitoring System (March 26, 2020)
  • K190574 — Patient Assistant Model PA97000 (September 24, 2019)
  • K182532 — Liba3 System (May 15, 2019)
  • K181658 — MobileECG 2 BT (March 26, 2019)

FDA data resources