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510(k) Data Aggregation
K Number
K070176Device Name
MAXHEALTH MECHANICAL WHEELCHAIR, K1
Manufacturer
Date Cleared
2007-03-01
(42 days)
Product Code
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
MAXHEALTH CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
Device Description
The MAXHEALTH Mechanical Wheelchair, K1 is 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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K Number
K001252Device Name
MAXHEALTH WHEELCHAIR, MODEL HE-8631, HE-8621, HE-8651
Manufacturer
Date Cleared
2000-06-12
(54 days)
Product Code
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
MAXHEALTH CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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