Shanghai SUNGO Lab
Hefei SUNGO Lab
FDA 510(k) testing for rehabilitation devices, supporting global market access
Electric wheelchairs, mobility scooters, walkers and crutches are a core strength of SUNGO Lab. We have completed more than 100 FDA 510(k) projects to date, including 36 cleared K-numbers for electric wheelchairs. We provide the full test scope - mechanical performance, electrical safety, EMC and environmental reliability - to help manufacturers enter global markets.
Wheelchairs - Technical requirements
Wheelchairs - Requirements and test methods (series)
Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods
Medical electrical equipment - General requirements for basic safety and essential performance
Medical electrical equipment - Electromagnetic disturbances - Requirements and tests
Physical medicine devices
Static stability, dynamic stability, braking performance and obstacle-climbing ability
Insulation resistance, dielectric strength, leakage current and earth continuity testing
Conducted emission, radiated emission, electrostatic discharge and surge immunity testing
High and low temperature, damp heat, vibration, shock and salt spray testing
Charge/discharge, overcharge, short circuit and crush safety testing
510(k) submission dossier preparation, performance testing and substantial equivalence comparison