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510(k) Data Aggregation
K Number
K033019Device Name
SUNPEX TECHNOLOGIES MODEL SE03
Manufacturer
Date Cleared
2004-01-22
(118 days)
Product Code
Regulation Number
890.3800Why did this record match?
Applicant Name (Manufacturer) :
SUNPEX TECHNOLOGY CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The intended use of the Model SE03 is to provide mobility to adults with the ability to place themselves in a sitting position on the Scooter and have the capacity to operate a simple hand control.
Device Description
Electric Powered Scooter, Model SE03
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K Number
K024175Device Name
SUNPEX TECHNOLOGIES MODEL PW
Manufacturer
Date Cleared
2003-05-01
(134 days)
Product Code
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
SUNPEX TECHNOLOGY CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The intended use of the Model PW is to provide mobility to adults with the ability to place themselves in a sitting position on the Wheelchair and have the capacity to operate a simple hand control.
Device Description
Model PW, Electric Power Wheelchair
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K Number
K021925Device Name
SUNPEX TECHNOLOGIES MODEL SE 01
Manufacturer
Date Cleared
2002-11-08
(150 days)
Product Code
Regulation Number
890.3800Why did this record match?
Applicant Name (Manufacturer) :
SUNPEX TECHNOLOGY CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The intended use of the Model SE 01 is to provide mobility to adults with the ability to place themselves in a sitting position on the scooter and have the capacity to operate a simple hand control.
Device Description
Model SE 01, Four Wheel Electric Scooter
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K Number
K021371Device Name
SUNSPEX TECHNOLOGIES MODEL SE 02
Manufacturer
Date Cleared
2002-05-16
(16 days)
Product Code
Regulation Number
890.3800Why did this record match?
Applicant Name (Manufacturer) :
SUNPEX TECHNOLOGY CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The intended use of the Model SE 02 is to provide mobility to adults with the ability to place themselves in a sitting position on the scooter and have the capacity to operate a simple hand control.
Device Description
Model SE 02, Three Wheel Electric Scooter
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