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510(k) Data Aggregation
K Number
K102910Device Name
MODEL LUNA MANUAL WHEELCHAIR
Manufacturer
Date Cleared
2010-12-23
(83 days)
Product Code
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
P.D.G., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
To provide mobility to persons limited to a seated position.
Device Description
The PDG Model Luna wheelchair is manually operated, self propelled mechanical wheelchair. Its intended function and use is to provide mobility to persons that may be limited to a seated position. It may also be used as attendant propelled transport device in a health care environment such as a hospital, nursing home or extended care facility.
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