Since 2022, 58 electric wheelchairs received FDA 510(K) clearance globally. 36 of them — 62.1% — came through us.
Folding power wheelchair, 6 km/h, lithium battery, 100 kg user weight. Cleared in 71 days after submission. Predicate device matched, no RFI.
4-wheel mid-size scooter, dual battery, 15 km range. Cleared on first review with substantial equivalence to predicate. EMC tested in-house.
Lightweight manual wheelchair for pediatric use, 50 kg max load. Custom seating compliance. Cleared in 86 days including pediatric review.
Self-propelled manual wheelchair with quick-release wheels. Full technical file prepared, DoC issued. Listed in EUDAMED Q1 2026.
Electric wheelchair with tilt-in-space function. Notified Body audit passed. Full STED package delivered, CE certificate issued.
Domestic NMPA Class II registration. GB/T 18029 full suite + GB 9706.1 electrical safety. Registration certificate issued in 14 months.
Since 2022, the FDA has cleared 58 electric wheelchairs for the US market.
36 of those 58 K-numbers were supported by our coaching and testing.
That's a 62.1% market share in a regulated specialty — the result of focus, not scale.
Tell us about your wheelchair, scooter, walker, or crutch. We'll map the standards and timeline.
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