K-numberK253075
Device nameMobility scooter (Air Classic); Mobility scooter (Air Traveller); Mobility scooter (Air Traveller2.0)
ApplicantSuzhou Sweetrich Vehicle Industry Technology Co., Ltd.
Product codeINI
Device classClass II
Decision dateJan 9, 2026
DecisionSubstantially Equivalent
Regulation890.3800
AI Summary extracted from FDA summary PDF · never regenerated
Intended use

The mobility scooter (Air Classic, Air Traveller, Air Traveller 2.0) is a motor-driven, indoor and outdoor transportation vehicle designed to provide mobility to disabled or elderly persons limited to a seated position. It features an aluminum frame, ABS body shell, rechargeable lithium-ion batteries, electromagnetic brakes, and a maximum load capacity of 120 kg.

Technological characteristics

The subject device uses lithium-ion batteries (24V/12AH) compared to the predicate's lead-acid batteries, has an aluminum frame versus carbon steel, and includes brushless motors (180W-250W) versus the predicate's 300W motor. The Air Classic has 3 wheels while Air Traveller models have 4 wheels. Minor differences exist in dimensions, wheel sizes, travel range, and slope grade ability, but all devices meet the same ISO 7176 series standards for wheelchairs and scooters.

Test standards cited

ISO 7176-1 through 7176-25 (wheelchair standards covering stability, braking, speed, strength, batteries, and electromagnetic compatibility), ISO 16840-10 (ignition resistance), IEC 60601-1-2:2014 (electromagnetic compatibility), IEC 62133-2:2021 (lithium battery safety), and ISO 10993-5 and 10993-10 (biocompatibility testing).

Substantial equivalence argument

Both devices share identical intended use, frame style (foldable seat, removable battery, disassemblable for transport), brake systems, and driving mechanisms. They comply with the same ISO standards and both meet electromagnetic compatibility and biocompatibility requirements. The differences in battery type, frame material, motor power, and dimensions do not introduce new safety or effectiveness concerns, as all performance tests validate the subject device meets the same standards as the predicate.

Extracted by AI from the official FDA summary PDF →
Source

View the full FDA submission: accessdata.fda.gov

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