FDA 510(k)

iBOT® PMD

K-Number: K243442 · 2025-01-30

Decision Date2025-01-30

Product CodeIMK

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

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 2025-01-30 under 510(k) number K243442. 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® PMD?

iBOT® PMD is a medical device that received FDA 510(k) clearance on 2025-01-30. The listed applicant is Mobius Mobility. The 510(k) number is K243442.

When did iBOT® PMD receive FDA 510(k) clearance?

iBOT® PMD received FDA 510(k) clearance on 2025-01-30, under 510(k) number K243442.

Who is the listed applicant for 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® PMD?

The FDA product code for 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.

K210920iBOT Personal Mobility Device (iBOT PMD)

Related Devices (Code: IMK)

K210920iBOT Personal Mobility Device (iBOT PMD)Mobius 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.