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Found 8 results
510(k) Data Aggregation
K Number
K052558Device Name
VCS, MODEL S4T
Manufacturer
CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER/CHC
Date Cleared
2005-10-27
(41 days)
Product Code
INI, 89I
Regulation Number
890.3800Why did this record match?
Applicant Name (Manufacturer) :
CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER/CHC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VCS S4T scooter is motor driven, indoor and outdoor transportation, vchicles with the intended use to provide mobility to disabled or civerly persons limited to a seated position.
Device Description
The VCS S4T scooter is an indoor/outdoor transportation vehicles which is battery operated. The movement of the scooter is controlled by a tiller handle and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.
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K Number
K051130Device Name
VCS S3Y
Manufacturer
CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER/CHC
Date Cleared
2005-09-09
(129 days)
Product Code
INI, 89I
Regulation Number
890.3800Why did this record match?
Applicant Name (Manufacturer) :
CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER/CHC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VCS S3Y scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.
Device Description
The VCS S3Y scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.
The VCS S3Y scooter is with a 136 kg (300 lbs) weight capacity.
The scooter is basic conventional rear wheel drive, rigid frame vehicle that are battery powered. It consists primarily of a welded steef frame, rear signal lights, a sealed transaxle motor drive system, electromagnetic braking system, electric motor controller, two batteries with an on-board charger and an adjustable seat.
It also includes a tiller handle for steering and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.
The scooter is powered by two 12 volt lead-acid DC batteries with 25 km (15 miles) with 21 AH which maximum speed upto 8.6 km/hr (5.4 mph).
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K Number
K051131Device Name
VCS S3T
Manufacturer
CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER/CHC
Date Cleared
2005-08-15
(104 days)
Product Code
INI, 89I
Regulation Number
890.3800Why did this record match?
Applicant Name (Manufacturer) :
CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER/CHC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VCS S3T scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.
Device Description
The VCS S3T scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position. The VCS S3T scooter is with a 136 kg (300 lbs) weight capacity. The scooter is basic conventional rear wheel drive, rigid frame vehicle that are battery powered. It consists primarily of a welded steel frame, rear signal lights, a sealed transaxle motor drive system, electromagnetic braking system, electric motor controller, two batteries with an on-board charger and an adjustable seat. It also includes a tiller handle for steering and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions. The scooter is powered by two 12 volt lead-acid DC batteries with 25 km (15 miles) with 21AH which maximum speed upto 6.6 km/hr (4.1 mph).
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K Number
K050507Device Name
SMARTECH, MODEL HOLI I
Manufacturer
CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER
Date Cleared
2005-07-07
(129 days)
Product Code
INI, 89I
Regulation Number
890.3800Why did this record match?
Applicant Name (Manufacturer) :
CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HOLI I scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.
Device Description
The HOLI I scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position. The HOLI I scooter is with a 130 kg (286 lbs) weight capacity. The scooter is basic conventional rear wheel drive, rigid frame vehicle that are battery powered. It consists primarily of a welded steel frame, lighting system, a sealed transaxle motor drive system, electromagnetic braking system, electric motor controller, two batteries with an off-board charger and an adjustable seat. It also includes a tiller handle for steering and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions. The scooter is powered by two 12 volt lead-acid DC batteries with 27 km (16.9 miles) with 32/36AH which maximum speed upto 9.5 km/hr (5.6 mph).
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K Number
K050793Device Name
LANDLEX MODEL S400X
Manufacturer
CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER
Date Cleared
2005-07-07
(101 days)
Product Code
INI, 89I
Regulation Number
890.3800Why did this record match?
Applicant Name (Manufacturer) :
CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LANDLEX S400X scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.
Device Description
The LANDLEX S400X scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.
The LANDLEX S400X scooter is with a 135 kg (300 lbs) weight capacity.
The scooter is basic conventional rear wheel drive, rigid frame vehicle that are battery powered. It consists primarily of a welded steel frame, lighting system, automatic headlight sensor, a sealed transaxle motor drive system, electromagnetic braking system, electric motor controller, two batteries with an off-board charger and an adjustable seat.
It also includes a tiller handle for steering and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.
The scooter is powered by two 12 volt lead-acid DC batteries with 35 km (22 miles) with 34AH which maximum speed upto 9 km/hr (5.6 mph).
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K Number
K050792Device Name
LANDLEX, MODEL S300X
Manufacturer
CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER
Date Cleared
2005-04-21
(24 days)
Product Code
INI, 89I
Regulation Number
890.3800Why did this record match?
Applicant Name (Manufacturer) :
CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LANDLEX S300X scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.
Device Description
The LANDLEX S300X scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.
The LANDLEX S300X scooter is with a 135 kg (300 lbs) weight capacity.
The scooter is basic conventional rear wheel drive, rigid frame vehicle that are battery powered. It consists primarily of a welded steel frame, lighting system, a auto light sensor, a sealed transaxle motor drive system, electromagnetic braking system, electric motor controller, two batteries with an off-board charger and an adjustable seat.
It also includes a tiller handle for steering and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions.
The scooter is powered by two 12 volt lead-acid DC batteries with 35 km (22 miles) with 34AH which maximum speed upto 8 km/hr (5 mph).
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K Number
K043326Device Name
BEWELL, MODEL SC 20
Manufacturer
CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER
Date Cleared
2005-01-26
(55 days)
Product Code
INI, 89I
Regulation Number
890.3800Why did this record match?
Applicant Name (Manufacturer) :
CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Bewell SC 20 scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.
Device Description
The Bewell SC 20 scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position. The Bewell SC 20 scooter is with a 130 kg (286 lbs) weight capacity. The scooter is basic conventional rear wheel drive, rigid frame vehicle that are battery powered. It consists primarily of a welded steel frame, lighting system, a sealed transaxle motor drive system, electromagnetic braking system, electric motor controller, two batteries with an off-board charger and an adjustable seat. It also includes a tiller handle for steering and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions. The scooter is powered by two 12 volt lead-acid DC batteries with 35.2 km (22 miles) with 36AH which maximum speed upto 9 km/hr (5.6 mph).
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K Number
K043332Device Name
WHEELCHAIR, MODEL 8500-II
Manufacturer
CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER
Date Cleared
2004-12-13
(11 days)
Product Code
IOR, 89I
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AIDC 8500-II Wheelchair is a tilt-in-space mobile positioning system for everyday indoor and outdoor use on flat terrain. They are available in a range of sizes to accommodate a particular fit to the user.
AIDC 8500-II Wheelchair can be an attendant propelled or self propelled device, its intended use is to enhance mobility to physically challenged persons limited to a sitting position on the flat and firm terrain in outdoor or indoor. It has various options to control and/or support the user's specific needs.
AIDC 8500-II Wheelchair is intended use to provide mobility to physically challenged persons limited to a sitting position on the flat and firm terrain in outdoor and indoor.
Device Description
The AIDC 8500-II Wheelchair is manually operated mechanical wheelchair. It is designed to be light in weight with folding frame. The range of sizes and configurations are available to accommodate the needs of each user. The wheelchair is suitable to provide mobility to user for both indoors and outdoors with firm surface that is free of climbing obstacles.
The AIDC 8500-II Wheelchair consists of typical components found on most manual wheelchair. The wheelchair consists of aluminum alloy frame constructed of AA6061-T6 aluminum alloy tubing that is TIG-welded, removable seat and back upholsteries, flip-up available footrest and legrest, front castors and rear wheels.
The owner's manual of AIDC 8500-II Wheelchair provides information on warnings, cautions and operation instruction of the wheelchair.
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