Search Results
Found 1 results
510(k) Data Aggregation
K Number
K250758Device Name
Electric Wheelchair (F309)
Manufacturer
CHANGSHU PINGFANG WHEELCHAIR CO., LTD
Date Cleared
2025-05-09
(57 days)
Product Code
ITI
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
CHANGSHU PINGFANG WHEELCHAIR CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This Electric Wheelchair is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
Device Description
The product is intended only carry one person and used as a means of transportation for the disabled, and sick.
The electric wheelchair is classified as class B and the maximum occupant mass is 120kg.
The Electric Wheelchair is a battery powered four wheeled vehicle.
It consists two Lithium batteries with an off-board battery charger, frame, controller, motors, seat with cushion, back support with cushion, control device (including the battery power indicator, power ON button, power OFF button, horn button, speed indicator, speed-up button, slow-l down button, joystick, charging port), arm supports, two rear wheels, two casters(front wheels), foot support, anti-tip devices, push handle.
The wheelchair can easily fold and unfold for transportation or storage.
Ask a Question
Page 1 of 1