Home / 510(k) Clearances / K150095

510(k) K150095

ReDs Wearable System by Sensible Medical Innovations , Ltd. — Product Code DSB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 2015
Date Received
January 16, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plethysmograph, Impedance
Device Class
Class II
Regulation Number
870.2770
Review Panel
CV
Submission Type

Other clearances by Sensible Medical Innovations , Ltd.

  • K180479 — ReDS System (February 28, 2019)

Other clearances for product code DSB

  • K250634 — BCM2-Body Composition Monitor (November 24, 2025)
  • K243727 — Re:Balans (October 16, 2025)
  • K250922 — Edema Guard Monitor (EGM) CardioSet-001 (September 9, 2025)
  • K232089 — SOZO Pro (October 17, 2023)
  • K223217 — Zynex Monitoring System, Model CM-1600 (June 16, 2023)
  • K211585 — Bodyport Cardiac Scale (July 29, 2022)
  • K203473 — SOZO (April 19, 2021)
  • K193410 — SOZO Body Fluid Analyzer (October 2, 2020)
  • K191697 — Cardiac Monitor 1500 (February 21, 2020)
  • K180479 — ReDS System (February 28, 2019)