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510(k) Data Aggregation
K Number
K031910Device Name
STAINLESS STEEL AQUATIC WHEELCHAIR
Manufacturer
Date Cleared
2003-07-25
(35 days)
Product Code
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
**DB PERKS **& ASSOCIATES LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This wheelchair is to provide mobility to persons limited to a sitting position being transported either by an attendant or self-propelled.
This device is designed to be a typical manual wheelchair for use in an aquatic center setting.
Device Description
The Stainless Steel Aquatic Wheelchair is a non-rigid style, folding wheelchair. The wheelchair is suitable to provide mobility indoors or in wet conditions on a firm surface free of obstructions.
Construction is typical for this style of wheelchair. Our chair uses a crossbraced, welded, stainless steel frame with slung fabric (seat and back); swing back armrests and removable foot riggings. The chair uses 8-inch caster wheels at the front for steering with rear push handles for attendant assisted propulsion and 24-inch rear drive wheels with hand rims for self-propulsion. Lever style wheel locks are used on this chair.
All parts on our wheelchair are fabricated from stainless steel and selected plastics suitable for use in a swimming pool environment. The chair can be submersed in pool water without any harmful effects.
Upholstery meets California Technical bulletin CAL 117 standard for flame retardancy.
Users manual provides information on warnings, cautions maintenance and operation instructions.
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