FDA 510(k)

iBOT® PMD

Número K: K243442 · 2025-01-30

Data da decisão2025-01-30

Código do produtoIMK

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

Outros registros que listam Mobius Mobility como candidato(a)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

K210920iBOT Personal Mobility Device (iBOT PMD)

Dispositivos Relacionados (Código: IMK)

K210920iBOT Personal Mobility Device (iBOT PMD)Mobius Mobility K172601Next Generation iBOTDeka Research & Development Corp.

Fonte oficial

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