FDA 510(k)

iBOT Personal Mobility Device (iBOT PMD)

K-Number: K210920 · 2021-06-16

Decision Date2021-06-16

Product CodeIMK

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

iBOT Personal Mobility Device (iBOT PMD) is the device name listed in this FDA 510(k) record. The listed applicant is Mobius Mobility. It received FDA 510(k) clearance on 2021-06-16 under 510(k) number K210920. The device is classified under product code IMK. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the iBOT Personal Mobility Device (iBOT PMD)?

iBOT Personal Mobility Device (iBOT PMD) is a medical device that received FDA 510(k) clearance on 2021-06-16. The listed applicant is Mobius Mobility. The 510(k) number is K210920.

When did iBOT Personal Mobility Device (iBOT PMD) receive FDA 510(k) clearance?

iBOT Personal Mobility Device (iBOT PMD) received FDA 510(k) clearance on 2021-06-16, under 510(k) number K210920.

Who is the listed applicant for iBOT Personal Mobility Device (iBOT PMD)?

The FDA 510(k) record lists Mobius Mobility as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iBOT Personal Mobility Device (iBOT PMD)?

The FDA product code for iBOT Personal Mobility Device (iBOT PMD) is IMK.

Other records listing Mobius Mobility as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243442iBOT® PMD

Related Devices (Code: IMK)

K243442iBOT® PMDMobius Mobility K172601Next Generation iBOTDeka Research & Development Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.