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FDA 510(k)

Handbike Batec Electric

K-Number: K241159 · 2025-03-07

ApplicantBatec Mobility, S.L.
Decision Date2025-03-07
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

What is the Handbike Batec Electric?

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

When was Handbike Batec Electric approved by the FDA?

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

What company makes Handbike Batec Electric?

Handbike Batec Electric is manufactured by Batec Mobility, S.L..

What is the FDA product code for Handbike Batec Electric?

The FDA product code for Handbike Batec Electric is ITI.

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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.

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