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Electric Wheelchair
Full performance, safety, EMC, and software validation for power wheelchairs targeting FDA 510(K), CE-MDR, and NMPA registration.
- ▸ Static & dynamic stability (ISO 7176-1/2)
- ▸ Braking (ISO 7176-3)
- ▸ Power & control systems (ISO 7176-14)
- ▸ EMC immunity & emissions (ISO 7176-21)
- ▸ Battery safety (IEC 62133)
- ▸ FDA 510(K) submission coaching
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Manual Wheelchair
Mechanical performance, durability, and ergonomic compliance for manual wheelchairs across global markets.
- ▸ Static stability (ISO 7176-1)
- ▸ Braking effectiveness (ISO 7176-3)
- ▸ Static / impact / fatigue (ISO 7176-8)
- ▸ Dimensions & mass (ISO 7176-5)
- ▸ Seating compliance (ISO 7176-7)
- ▸ CE-MDR technical file support
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Mobility Scooter
Whole-vehicle testing for 3-wheel and 4-wheel scooters, including range, slope, and obstacle clearance.
- ▸ Vehicle-level performance
- ▸ Battery & charger safety
- ▸ EMC compliance
- ▸ Software validation (IEC 62304)
- ▸ ANSI/RESNA WC-1 & WC-2
- ▸ FDA pre-submission strategy
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Walker & Crutch
Class I device testing for walkers, rollators, crutches, and canes — load, fatigue, slip resistance, height adjustment.
- ▸ Load capacity (ASTM F1825)
- ▸ Fatigue & cycling tests
- ▸ Height adjustment force
- ▸ Slip resistance (rubber tip)
- ▸ Folding mechanism endurance
- ▸ FDA Class I registration
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