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510(k) Data Aggregation
K Number
K082246Device Name
DIGNITY 100
Manufacturer
DIGNITY MEDICAL DEVICES, INC
Date Cleared
2008-09-09
(32 days)
Product Code
IOR
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
DIGNITY MEDICAL DEVICES, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Dignity 100 is a manually operated device with wheels that is intended for medical purposes to provide mobility to physically challenged persons. The Dignity 100 is intended for indoor and outdoor use on firm surfaces free of climbing obstacles.
To provide mobility for the disabled.
Device Description
The Dignity 100 is a manually operated device with wheels that is intended for medical purposes to provide mobility to physically challenged persons. The Dignity 100 is intended for indoor and outdoor use on firm surfaces free of climbing obstacles.
The Dignity 100 functions like a standard mechanical wheelchair with the addition of a custom cushion. This 21 CFR Sec. 890.3920 wheelchair component is intended for medical o rurgoses and surface an integral part of the wheelchair, but will also be sold separately as a replacement part. The custom cushion is designed with a keyhole shaped drop down panel which is replacement by the patient when he or she wishes to use the toilet.
The Dignity 100 is constructed from 7/8 inch outside diameter (OD) round, mechanical steel tubing. The chair is of welded construction. The sewn components are secured to the frame using screws and bolts. This device is a rigid wheelchair that incorporates a seating surface. The Dignity 10 has removable footrests.
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