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510(k) Data Aggregation
K Number
K984367Device Name
ACTIVX
Manufacturer
Date Cleared
1999-01-28
(52 days)
Product Code
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
ADORNO ROGERS TECHNOLOGY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Wheelchair mobility, either self-propelled or propelled by an attendant, for the physically impaired.
Device Description
The wheelchair is a standard lightweight manual folding chair that provides mobility based on an individual user's needs and capabilities. Since it has the same intended use as typical wheelchairs, its features are also comparable. A sling seat and backrest are affixed to a sturdy frame that is supported by two large rear wheels and two forward swivel caster wheels. The two side frames are connected by a horizontal cross brace, rather than a vertical cross brace, that can assume a folded configuration. The wheelchair accommodates removable armrests, detachable footrests, rear anti-tippers, push handles, and wheel locks.
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