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510(k) Data Aggregation
K Number
K041336Device Name
PRO WALKER PL-200 POWER WHEELCHAIR
Manufacturer
PRO WALKER INC.
Date Cleared
2004-07-20
(62 days)
Product Code
ITI
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
PRO WALKER INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
Device Description
The PRO WALKER Power Wheelchair, PL-200 is an indoor / outdoor Powered Wheelchair that is battery operated. It has a base with four-wheeled with a seat. The movement of the Wheelchair is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.
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K Number
K041337Device Name
PRO WALKER ML-300 FOLDABLE WHEELCHAIR
Manufacturer
PRO WALKER INC.
Date Cleared
2004-05-28
(9 days)
Product Code
IOR
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
PRO WALKER INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
Device Description
The PRO WALKER ML-300 Foldable Wheelchair is an indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The device can be disassembled for transport and it is foldable easily. The device uses a standard sling type back and seat, the upholstery fabric meets the California Technical Bulletin CAL 117 standard for flame retardant.
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