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Vitalconnect Inc.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
10
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2537-2020Class IIVistaSolution, physiological signal transmitter. A software graphical user interface for use by heaMay 21, 2020

Recent 510(k) Clearances

K-NumberDeviceDate
K242129VitalRhythmApril 17, 2025
K193343Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed)April 20, 2020
K192757VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor – bag ofFebruary 6, 2020
K190916VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20June 7, 2019
K183078VitalConnect Platform, VitalPatch BiosensorMarch 7, 2019
K163453VitalPatch® VitalConnect PlatformNovember 2, 2017
K170973VitalWatch Software User InterfaceJune 2, 2017
K152139Vital Connect Platform, HealthPatch MD, VitalPatchDecember 6, 2015
K141167VITALCONNECT PLATFORM (CONSISTING OF VITALCONNECT SENSOR, RELAY SOFTWARE LIBRARY AND SECURE SERVER SJuly 29, 2014
K132447VITALCONNECT PLATFORM BY VITAL CONNECT INC.April 3, 2014