iBOT Personal Mobility Device (iBOT PMD)— 510(k) K210920

Name: FDA 510(k) clearance K210920
Creator: U.S. Food and Drug Administration
Published: 2021-06-16

Substantially Equivalent

Mobius Mobility

FDA 510(k) clearance K210920 for iBOT Personal Mobility Device (iBOT PMD), Substantially Equivalent on 2021-06-16. Applicant: Mobius Mobility. Device class: 2.

Clearance details

Applicant: Mobius Mobility
Product code: Code IMK
Device class: Class 2
Regulation: 21 CFR 890.3890
Advisory panel: Physical Medicine
Date received: 2021-03-29
Decision date: 2021-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Manchester, NH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IMK

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K243442 — iBOT® PMD2025-01-30
K172601 — Next Generation iBOT2018-03-02

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