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510(k) Data Aggregation
K Number
K092130Device Name
RASCAL WE GO 250 POWERED WHEELCHAIR
Manufacturer
Date Cleared
2009-09-21
(68 days)
Product Code
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
ELECTRIC MOBILITY CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The device is intended to provide mobility to persons restricted to a seated position or who are mobility impaired.
Device Description
The Rascal "We Go 250" Powered Wheelchair is an indoor/outdoor use battery operated wheelchair. It has a frame with four (4) wheels, a seat, two (2) arm rests and a seat belt. The primary technology advantage of this device is that the movement of the wheelchair can be controlled by the rider or an attendant using hand controls located at the top of steering column to adjust the speed and direction of the wheelchair with occupant therein. These hand controls for the attendant are the same controls used for most electric scooters (Motorized Three Wheeled Vehicles - Regulation Number 890.3800). We currently market electric scooters with that same technology (510k K002616). The brake mechanism is activated or deactivated dependant upon the use of the hand controls located at the top of the steering column.
The base of the wheelchair is same base currently used on 510k approved device (K013788)
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K Number
K002616Device Name
ELECTRIC MOBILITY RASCAL AND CHAUFFER SCOOTERS
Manufacturer
Date Cleared
2000-12-11
(111 days)
Product Code
Regulation Number
890.3800Why did this record match?
Applicant Name (Manufacturer) :
ELECTRIC MOBILITY CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K991281Device Name
ELECTRIC MOBILITY CAVALIER SCOOTERS
Manufacturer
Date Cleared
1999-10-27
(196 days)
Product Code
Regulation Number
890.3800Why did this record match?
Applicant Name (Manufacturer) :
ELECTRIC MOBILITY CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Electric Mobility Cavalier Scooter is intended to serve the needs of individuals who have limited mobility.
Device Description
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K Number
K972370Device Name
RASCAL POWER CHAIR
Manufacturer
Date Cleared
1997-11-14
(142 days)
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
ELECTRIC MOBILITY CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Electric Mobility RASCAL Power Wheelchair is intended to serve the needs of individuals who have very limited mobility and a reduced capacity to steer or maneuver a wheelchair without some type of power assistance. While this product is specifically targeted to the outdoor market, its design is adaptable for indoor use as well. It is substantially equivalent to several power chairs currently on the market as described later in this application. It is extremely stable and durable and it is designed to carry up to 250 pounds on our standard unit and 400 pounds on our heavy duty unit. It is capable of operating over smooth indoor surfaces, or moderately rough, moderately soft, and uneven outdoor surfaces. It is capable of negotiating small obstacles and its spring suspension provides for a smooth ride and easier handling.
Device Description
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