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Found 4 results
510(k) Data Aggregation
K Number
K071444Device Name
MECHANICAL WHEELCHAIR - L-FRAME SERIES
Manufacturer
COLOURS 'N MOTION
Date Cleared
2007-07-27
(64 days)
Product Code
IOR
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
COLOURS 'N MOTION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K030017Device Name
CHUMP
Manufacturer
COLOURS 'N MOTION
Date Cleared
2003-05-01
(119 days)
Product Code
IOR
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
COLOURS 'N MOTION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
for the indications for use stated in the enclosure
Device Description
Mechanical Wheelchair "CHUMP", "KRYPTO"
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K Number
K010823Device Name
SPAZZ
Manufacturer
COLOURS 'N MOTION
Date Cleared
2001-04-27
(39 days)
Product Code
IOR
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
COLOURS 'N MOTION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K984354Device Name
MECHANICAL WHEELCHAIR
Manufacturer
COLOURS 'N MOTION
Date Cleared
1999-01-28
(55 days)
Product Code
IOR
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
COLOURS 'N MOTION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Our new Wheelchair, Zephyr is not envisioned nor will it be marketed to a first time user but rather directed to a handicapped user who has become relatively proficient in the use of a wheelchair. And who is seeking a lighter and more maneuverable wheelchair for use in sports and athletic enhancement.
Device Description
Not Found
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