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Found 3 results
510(k) Data Aggregation
K Number
K051090Device Name
X-CHANGE
Manufacturer
Date Cleared
2005-05-13
(15 days)
Product Code
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
MEYRA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The X-Change wheelchair family is designed mostly for adults who require assistance in the use of a device to assist them with their mobility needs.
Device Description
Not Found
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K Number
K050941Device Name
BRIX WHEELCHAIR
Manufacturer
Date Cleared
2005-05-05
(21 days)
Product Code
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
MEYRA, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The BRIX wheelchair is designed for children who have physical impairments that require the use of a device to assist them with their mobility needs. This device is intended solely for pediatric use.
Device Description
BRIX wheelchair
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K Number
K050560Device Name
EUROCHAIR
Manufacturer
Date Cleared
2005-04-21
(49 days)
Product Code
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
MEYRA, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The EUROCHAIR wheelchair family is designed mainly for adults with physical impairments that require the use of a device to assist them with their mobility needs.
Device Description
Not Found
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