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510(k) Data Aggregation
K Number
K152827Device Name
Weely Manual Wheelchair
Manufacturer
Date Cleared
2016-02-19
(143 days)
Product Code
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
Rupiani
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The indications for use for the Weelchair is to provide mobility to persons limited to a sitting position.
Device Description
The Rupiani Weely Manual Wheelchair (Weely) is a manually operated, user propelled, manual, mechanical wheelchair. It's intended function and use is to provide mobility to persons limited to a sitting position. It may also be used in as an attendant propelled transport device in a health care environment such as a hospital, nursing home or extended care facility.
The Weely consists primarily of an upper and lower frame assembly, upholstery for seating, large wheels for propelling the chair and rear swivel type pivoting casters for turning. The wheels and casters are mounted to the lower frame assembly. The wheelchair seat and back mount to the upper frame assemblies are constructed from aluminum tubing. The rear casters act as "anti-tippers and provide added stability
The lower frame is of rigid (non-folding) design. The back rest can be folded to allow for storage and transport of the chair when it is not in use. The Weely is equipped with a Varilite rigid backrest and a Varilite EVOLUTION cushion covered by SooFleece III mesh fabric provided by Ventex. The upholstery materials meet the requirements of ISO 8191-1 Part 1:Ignition Source: Smoldering Cigarette and - ISO 8191-2 Part 2: Ignition Source: Flame Match-Flame Equivalent Standard for Resistance to Ignition of Upholstered Parts.
The Weely includes a tilt mechanism which allows the seat and back of the wheelchair to be tilted. This feature is used to provide comfort to those users who may be confined to the wheelchair for extended periods of time. The tilt mechanism can also serve as an attendant aid in those situations where a patient needs to be tilted for attendant access.
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K Number
K992310Device Name
TONICROSS TRICYCLES, MODELS, T0, T1,T2,T3 AND T4.
Manufacturer
Date Cleared
1999-11-02
(116 days)
Product Code
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
RUPIANI MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
These devices are tricycles that are indicated for use with people, from children to adults, some of whom may have motor disabilities.
Device Description
These devices are tricycles
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