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510(k) Data Aggregation
K Number
K113463Device Name
POWER WHEELCHAIR
Manufacturer
SUZHOU KD MEDICAL APPLIANCE CO., LTD.
Date Cleared
2012-04-06
(136 days)
Product Code
ITI
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
SUZHOU KD MEDICAL APPLIANCE CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device 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 PL001 powered 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. It consists of two foldable armrests, a seat belt, a backrest, a seat cushion, a foldable frame, two rear drive wheels with hub motor/electromagnetic brake assemblies, two pivoting casters, two Li-ion batteries, an off-board battery charger, a control panel with connect cables and a electric motor controller. The device is powered by two 12 volt, 10 Ah, Li-ion batteries with 20 km(12.5 miles) range that can be recharged by an off-board battery charger that can be plugged into an AC outlet (110-220 V, 50-60 Hz) when the device is not in use. The patient can activate the joystick to move in the direction of the joystick is actuated. When the patient releases the joystick the device slows to stop and the brakes are automatically re-engaged.
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K Number
K100824Device Name
MECHANICAL WHEELCHAIR, MODEL DS 202-S
Manufacturer
SUZHOU KD MEDICAL
Date Cleared
2010-05-25
(62 days)
Product Code
IOR
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
SUZHOU KD MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DS 202-S manual wheelchair is intended use to provide mobility to physically challenged persons limited to a sitting position on the flat and firm terrain in outdoor and indoor.
Device Description
DS 202-S manual wheelchair is intended use to provide mobility to physically challenged persons limited to a sitting position on the flat and firm terrain in outdoor and indoor. It consists of a rigid, mechanical and foldable steel frame and nylon upholstery back and seat. It has two 24" rear wheels and two 8" front casters for turning and maneuverability.
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