FDA 510(k)

Handbike Batec Electric

Número K: K241159 · 2025-03-07

Data da decisão2025-03-07

Código do produtoITI

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

Handbike Batec Electric is the device name listed in this FDA 510(k) record. The listed applicant is Batec Mobility, S.L.. It received FDA 510(k) clearance on 2025-03-07 under 510(k) number K241159. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Handbike Batec Electric?

Handbike Batec Electric is a medical device that received FDA 510(k) clearance on 2025-03-07. The listed applicant is Batec Mobility, S.L.. The 510(k) number is K241159.

When did Handbike Batec Electric receive FDA 510(k) clearance?

Handbike Batec Electric received FDA 510(k) clearance on 2025-03-07, under 510(k) number K241159.

Who is the listed applicant for Handbike Batec Electric?

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

What is the FDA product code for Handbike Batec Electric?

The FDA product code for Handbike Batec Electric is ITI.

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