ReDs Wearable System— 510(k) K150095

Name: FDA 510(k) clearance K150095
Creator: U.S. Food and Drug Administration
Published: 2015-08-06

Substantially Equivalent

Sensible Medical Innovations , Ltd.

FDA 510(k) clearance K150095 for ReDs Wearable System, Substantially Equivalent on 2015-08-06. Applicant: Sensible Medical Innovations , Ltd.. Device class: 2.

Clearance details

Applicant: Sensible Medical Innovations , Ltd.
Product code: Code DSB
Device class: Class 2
Regulation: 21 CFR 870.2770
Advisory panel: Cardiovascular
Date received: 2015-01-16
Decision date: 2015-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Netanya, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code DSB

view all

K260224 — MySOZO Software version 6.1.0.1 (SW version 6.1.0.1)2026-08-17
K250634 — BCM2-Body Composition Monitor2025-11-24
K243727 — Re:Balans2025-10-16
K250922 — Edema Guard Monitor (EGM) CardioSet-0012025-09-09
K232089 — SOZO Pro2023-10-17

More clearances from Sensible Medical Innovations , Ltd.

view all

K180479 — ReDS System2019-02-28

Data sourced from openFDA. This site is unofficial and independent of the FDA.