The guidance is applied to O.3860 Powered wheelchair which is identified as a battery-operated device that is intended for medical purposes to provide mobility to people restricted to a sitting position. The maximum speed limit of powered wheelchairs is 10 km/h. This classification also includes external power components used in mechanical wheelchairs.

Product description and specification:
Manufactures or brand owners should provide the following information:

1. Collocative mechanical wheelchairs (E.g. brand, model, combination method or license no.) and precautions
2. Battery Specification, including the type of battery (E.g. lead storage battery or lithium battery)
3. Battery Power Indicator
4. Charger
5. Charge Time
6. User Mass
7. Maximum Drive Distance
8. Maximum Speed
9. Motor
10. Brake
11. Climbing Angle
12. Wheel Size
13. Braking Method
14. Minimum Turning Space
15. Total weight

Safety and performance data:
If any of the tests below were not performed, related literature or scientific evaluation report should be submitted to confirm product safety and performance. If the applied testing methods were different from those listed in references, (1) for the ones possess equivalence, methods should be submitted for audit, (2) for the ones without equivalence, methods along with related literature or scientific evaluation report should be submitted to explain the establish basis of the methods. 




Electromagnetic Compatibility Test

The product should function satisfactorily in its electromagnetic environment without introducing intolerable electromagnetic disturbance to other equipment in the environment.


Biocompatibility Test



Irritation or Intracutaneous Reactivity


Software Validation

Software validation is essential for products utilizing software controls.


Performance Test

Static Stability

Dynamic Stability

Efficiency of Brakes

Energy Consumption

Overall Dimensions, Mass, and Turning Space

Maximum Speed, Acceleration and Deceleration

Static, Impact and Fatigue Strengths

Climatic Test

Obstacle-climbing Ability

Power and Control System

Resistance to Ignition of Upholstered


Clamping Force

Quick-release mechanisms


TW: Guidance for Pre-clinical Testing of Soft Contact Lenses

- TW: TFDA Published Guidance for Applying Human Factors/Usability Engineering Evaluation to Medical Devices