Handbike Batec Electric (K241159) - FDA 510(k) Clearance

K241159 is an FDA 510(k) clearance for the Handbike Batec Electric. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Batec Mobility, S.L. (Sant Quirze Del Vallès, ES). The FDA issued a Cleared decision on March 7, 2025 after a review of 315 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3860 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

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