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510(k) Data Aggregation
K Number
K981557Device Name
MYCYCLE, HANDMASTER, VICTORY
Manufacturer
Date Cleared
1998-07-09
(69 days)
Product Code
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
RICHVALE LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The intended use of the device is as a wheelchair. The wheelchair and drive system empower physically challenged persons by providing a means of mobility. This includes temporary and permanent conditions in all ages, including but not limited to Arthritis, paraplegic, Quadriplegic, Multiple Sclerosis and other immobilizing or debilitating conditions. Our device and the predicate device provide the same function for occupants who are unable to move due to injuries or other medical conditions.
Device Description
The MyCycle Handmaster Victory wheelchair comprises a wheelchair and a drive unit for powering the wheelchair. The wheelchair comprises a substantially identical device as the Quickie 2hp Titanium Wheelchair. The measurements of each dimension, as well as the construction materials, and the type of welding techniques utilized are substantially identical. based on the documentation available to applicant regarding this wheelchair. The only difference is that the MyCvcle device is not of Titanium but of conventional metal materials. However, the maximum weight bearing capacity, the tiltover testing, the dimensions and the weight of the device are identical.
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K Number
K981558Device Name
MYCYCLE HANDMASTER, LIGHT
Manufacturer
Date Cleared
1998-07-09
(69 days)
Product Code
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
RICHVALE LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The intended use of the device is as a wheelchair. The wheelchair and drive system empower physically challenged persons by providing a means of mobility. This includes temporary and permanent conditions in all ages, including but not limited to Arthritis, paraplegic, Quadriplegic, Multiple Sclerosis and other immobilizing or debilitating conditions. Our device and the predicate device provide the same function for occupants who are unable to move due to injuries or other medical conditions.
Device Description
The MyCycle Handmaster Light wheelchair comprises a wheelchair and a drive unit for powering the wheelchair. The wheelchair comprises a substantially identical device as the Breezy Wheelchair (K880280). The measurements of each dimension, as well as the construction materials, and the type of welding techniques utilized are substantially identical, based on the documentation available to applicant regarding this wheelchair. The only difference is that in place of a single wheel carrier, the MyCycle Handmaster Light wheelchair instead utilizes two vertical carriers in parallel to better distribute the load. Accordingly, the maximum weight bearing capacity, the tiltover testing, the dimensions and the weight of the device are identical.
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