The Wheelchair Specialist

Tested. Certified.
Trusted by 62% of FDA wheelchair clearances since 2022.

SUNGO Mobility is the dedicated testing lab for wheelchairs, scooters, walkers, and crutches. Full ISO 7176 suite, FDA 510(K) coaching, CE-MDR support — under one roof, average 58-day cycle.

62.1%
FDA 510(K) Market Share
36
Cleared K-Numbers
58d
Average Cycle
100%
Pass-Through Rate
What We Test

Four Product Categories. One Lab.

Every wheelchair, scooter, walker, and crutch deserves a specialist. We don't do everything — we do mobility, deeply.

Electric Wheelchair

Power performance, battery safety, control systems, EMC, and full FDA 510(K) submission support.

ISO 7176-14 ISO 7176-21 FDA 510(K)
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Manual Wheelchair

Static stability, dynamic durability, brake performance, frame strength to ISO 7176-1/3/5/7/8.

ISO 7176-1 ISO 7176-8 CE-MDR
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Mobility Scooter

Vehicle-level performance, battery, software validation, dynamic stability for FDA & CE markets.

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

Walker & Crutch

Load capacity, fatigue testing, height adjustment, slip resistance per ASTM F1825 / ISO 11334.

ASTM F1825 ISO 11334 FDA Class I
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Standards Coverage

From ISO to FDA — One Test, Global Routes.

ISO 7176-1
Static Stability
ISO 7176-2
Dynamic Stability
ISO 7176-3
Braking Effectiveness
ISO 7176-5
Dimensions / Mass
ISO 7176-7
Seating Dimensions
ISO 7176-8
Static / Impact / Fatigue
ISO 7176-14
Power & Control
ISO 7176-21
EMC Requirements
ANSI/RESNA WC
Wheelchair Standards (US)
FDA 21 CFR 890
Physical Medicine Devices
ASTM F1825
Walker / Rollator
ISO 11334
Crutches / Canes
Why Mobility Brands Choose Us

A Specialist Beats a Generalist.

SUNGO Mobility General-Purpose Lab
Wheelchair-only focus✓ Dedicated teamMixed with other products
FDA 510(K) coaching✓ 36 K-numbers since 2022Testing only
ISO 7176 full suite✓ -1 to -28 in-housePartial / subcontracted
Average cycle✓ 58 days90 - 120 days
Triple accreditation✓ CNAS + CMA + IASCNAS or CMA only
FDA RFI response✓ < 72h with engineer callEmail only, days

Ship Your Sample. Get Your K-Number.

From inquiry to FDA clearance — one project manager, one report, one route to market.

Start a Project