MSUNGO Mobility
Track Record

36 cleared K-numbers.
One specialist lab.

Since 2022 we have supported 36 electric wheelchair FDA 510(K) clearances.

36
FDA 510(K) Cleared
14
CE-MDR Certified
9
NMPA Class II Registered
58d
Average Cycle
Recent Wins

Selected Case Studies

FDA 510(K)

Electric Wheelchair — K252517

Folding power wheelchair, 6 km/h, lithium battery, 100 kg user weight. Cleared in 71 days after submission. Predicate device matched, no RFI.

ISO 7176-1/2/3/14/21 IEC 62133
FDA 510(K)

Mobility Scooter — K251565

4-wheel mid-size scooter, dual battery, 15 km range. Cleared on first review with substantial equivalence to predicate. EMC tested in-house.

ANSI/RESNA WC-1/2 UL 2271
FDA 510(K)

Pediatric Wheelchair — K252502

Lightweight manual wheelchair for pediatric use, 50 kg max load. Custom seating compliance. Cleared in 86 days including pediatric review.

ISO 7176-1/3/5/7/8 FDA Pediatric
CE-MDR

Manual Wheelchair — Class I

Self-propelled manual wheelchair with quick-release wheels. Full technical file prepared, DoC issued. Listed in EUDAMED Q1 2026.

EN 12183 ISO 7176
CE-MDR

Powered Wheelchair — Class IIa

Electric wheelchair with tilt-in-space function. Notified Body audit passed. Full STED package delivered, CE certificate issued.

EN 12184 EU MDR 2017/745
NMPA

Electric Wheelchair — Class II

Domestic NMPA Class II registration. GB/T 18029 full suite + GB 9706.1 electrical safety. Registration certificate issued in 14 months.

GB/T 18029 GB 9706.1
By the Numbers

How a Specialist Lab Wins This Work


36 of those 58 K-numbers were supported by our coaching and testing.
That is the result of focus, not scale.

Your Product Could Be Case #37.

Tell us about your wheelchair, scooter, walker, or crutch. We'll map the standards and timeline.

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