Home / 510(k) Clearances / K192757

510(k) K192757

VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor – bag of 20, VitalPatch 7D Biosensor – bag of 20 by Vitalconnect, Inc. — Product Code DRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 2020
Date Received
September 30, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
Device Class
Class II
Regulation Number
870.2910
Review Panel
CV
Submission Type

Other clearances by Vitalconnect, Inc.

  • K242129 — VitalRhythm (April 17, 2025)
  • K193343 — Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTabl (April 20, 2020)
  • K190916 — VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20 (June 7, 2019)
  • K183078 — VitalConnect Platform, VitalPatch Biosensor (March 7, 2019)
  • K163453 — VitalPatch® VitalConnect Platform (November 2, 2017)
  • K170973 — VitalWatch Software User Interface (June 2, 2017)
  • K152139 — Vital Connect Platform, HealthPatch MD, VitalPatch (December 6, 2015)
  • K141167 — VITALCONNECT PLATFORM (CONSISTING OF VITALCONNECT SENSOR, RELAY SOFTWARE LIBRARY (July 29, 2014)
  • K132447 — VITALCONNECT PLATFORM BY VITAL CONNECT INC. (April 3, 2014)

Other clearances for product code DRG

  • K252984 — Perin Health System (PHD80060-2) (January 22, 2026)
  • K252440 — EasyTeleMed (2.0.2) (October 2, 2025)
  • K250259 — TeleRehab Aermos Cardiopulmonary Rehabilitation (June 4, 2025)
  • K243837 — iBSM (May 16, 2025)
  • K242018 — UbiqVue™ 2A Multi-parameter System (UX2550) (November 12, 2024)
  • K241101 — BioButton System (September 26, 2024)
  • K240251 — ANNE Chest (June 3, 2024)
  • K223711 — ANNE One (August 10, 2023)
  • K220526 — HD+12, HD+15 (May 15, 2023)
  • K223073 — Alio (March 17, 2023)