K-numberK241159
Device nameHandbike Batec Electric
ApplicantBatec Mobility, S.L.
Product codeITI
Device classClass II
Decision dateMar 7, 2025
DecisionSubstantially Equivalent
Regulation890.3860
AI Summary extracted from FDA summary PDF · never regenerated
Intended use

The Handbike Batec Electric is a handcycle mechanism that attaches to a manual wheelchair to form a three-wheeled vehicle powered by an electric motor in the front wheel. It is designed to add auxiliary power to manual wheelchairs, increasing mobility and independence for wheelchair users with motor disabilities for both indoor and outdoor use without requiring professional operation or training.

Technological characteristics

The device features a brushless motor (350W nominal for Mini 2, 1440W nominal for Scrambler 2), Li-ion batteries (36V or 48V in multiple capacities), two mechanical brakes with automatic electronic speed limiting to ≤120% of set limit, LCD display, direct drive with handlebar and twist throttle steering, maximum forward speed of 15 km/h, and aluminum frame construction. It differs from the predicate primarily in motor power levels, battery configurations, frame materials (7005-T6 vs 6061-T6 aluminum), and weight capacity (110 kg vs 120 kg predicate).

Test standards cited

ISO 7176 series standards for wheelchairs (parts 1, 2, 3, 4, 5, 6, 8, 9, 10, 11, 13, 14, 15, 21); IEC 60601-1-2:2014 + A1:2020 for electromagnetic compatibility; IEC 62133-2 Edition 1.0 2017-02 for lithium battery safety.

Substantial equivalence argument

The device shares identical intended use, indications for use, operational principles, and general architecture with the predicate—both are add-on power units for manual wheelchairs forming three-wheel vehicles with similar control methods, braking systems, and performance envelopes. The minor differences in motor power, battery capacity, frame material, and weight limit do not affect safety or effectiveness because all variants comply with the same ISO 7176 wheelchair standards, employ the same fundamental technology, and produce equivalent clinical outcomes for the intended user population.

Extracted by AI from the official FDA summary PDF →
Source

View the full FDA submission: accessdata.fda.gov

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