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Found 3 results
510(k) Data Aggregation
K Number
K170701Device Name
GEN_2 and GEN_3 Mechanical Wheelchairs
Manufacturer
Date Cleared
2017-03-24
(16 days)
Product Code
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
Free Wheelchair Mission
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The GEN 2 Mechanical Wheelchair is intended to provide mobility to persons restricted to a seated position. The GEN 3 Mechanical Wheelchair is intended to provide mobility to persons restricted to a seated position.
Device Description
The GEN 2 mechanical wheelchair is a highly adaptable allpurpose wheelchair created for use in developing countries, while allowing for a healthy, personalized fit. The wheelchair features adjustable seating, large castor wheels, an extra-thick cushion and adjustable footrests.
The GEN 3 Mechanical Wheelchair is a folding, non-rigid type wheelchair designed for use over rough terrain in developing countries. The wheelchair features adjustable seating, large castor wheels, an extra-thick cushion and adjustable footrests.
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K Number
K141691Device Name
GEN_3
Manufacturer
Date Cleared
2014-12-17
(176 days)
Product Code
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
FREE WHEELCHAIR MISSION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The GEN_3 Mechanical Wheelchair is intended to provide mobility to persons restricted to a seated position.
Device Description
The GEN 3 Mechanical Wheelchair is a folding, non-rigid type wheelchair designed for use over rough terrain in developing countries. The wheelchair features adjustable seating, large castor wheels, an extra-thick cushion and adjustable footrests.
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K Number
K113713Device Name
GEN_2 MECHANICAL WHEELCHAIR
Manufacturer
Date Cleared
2012-05-07
(140 days)
Product Code
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
FREE WHEELCHAIR MISSION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The GEN 2 Mechanical Wheelchair is intended to provide mobility to persons restricted to a seated position.
Device Description
The GEN 2 mechanical wheelchair is a highly adaptable all-purpose wheelchair created for use in developing countries, while allowing for a healthy, personalized fit. The wheelchair features adjustable seating, large castor wheels, an extra-thick cushion and adjustable footrests.
Ask a Question
Ask a specific question about this device
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