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510(k) Data Aggregation
K Number
K202506Device Name
Karma Powered Wheelchair
Manufacturer
Karma Medical Products Co., Ltd.
Date Cleared
2021-04-19
(231 days)
Product Code
ITI
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
Karma Medical Products Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Device Description
KP-10.3S is meant to provide mobility to persons who are not able to walk, stand or use a manual wheelchair, but who are very well able to control and use the interface of an electrically powered wheelchair is not suitable for persons who do not have the cognitive skills to drive an electrically powered wheelchair by themselves. Also, it is not suitable for visually impaired persons. This wheelchair is suitable for users up to 264 lbs. (120 kg) in weight.
KP-10.3S is classified as a class B mobility product for indoor and outdoor use. It also has an extremely durable steel frame with tough components and does not suffer in dramatic extremes of temperature (neither the operator nor the attendant need touch metal parts in normal use). The compact size of this wheelchair, the excellent speed range and battery capacity makes the wheelchair suitable for both indoor and outdoor use. The KP-10.3S can be disassembled into four parts easily and can also be quickly assembled, which is convenient for storage and transportation.
The powered wheelchair KP-10.3S is an affordable rear wheel drive power chair. It features the patented S-Ergo Seating System and promotes a comfortable seating and a good posture. The device is powered by two 12 volt / 22 Ah lead acid batteries with 8.75 miles travel range that can be recharged by an off-board battery charger that can be plugged into an AC outlet (100 -240 V, 50-60 Hz), when the device is not in use.
Compact design makes it ideal for confined spaces mobility and short distance journey. The 36 inches turning radius for easy entry and exit of small elevator, making indoor activity effortless. It is tool-free disassembly, and can be easily placed in a car trunk, making travel possible and simple.
There are flip-back and height adjustable armrest, swing-away detachable footrest for KP-10.3S, and tool-free inclination angle adjustable backrest (15° - 27°) for KP-10.3S. The optional quick release steering controller enables maneuvering switches from the user to the attendants in seconds. The user can activate the joystick to move in the direction of the joystick is actuated. When the user releases the joystick, the device slows to stop and the brakes are automatically re-engaged. The maximum weight capacity of KP-10.3S is 264 lbs and its maximum speed is 3.75 mph.
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K Number
K062309Device Name
KARMA MANUAL WHEELCHAIR, MODELS S-ERGO 305 AND S-ERGO 105
Manufacturer
KARMA MEDICAL PRODUCTS CO., LTD.
Date Cleared
2006-10-10
(63 days)
Product Code
IOR
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
KARMA MEDICAL PRODUCTS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
Device Description
The KARMA Manual Wheelchair, S-Ergo 305 & S-Ergo 105 are indoor / outdoor wheelchairs that have the base with four-wheeled with a seat. The devices can be disassembled for transport and it is foldable easily. Back upholstery material is also the same resistance-ignitability fabric.
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K Number
K062311Device Name
KARMA MANUAL WHEELCHAIR, MODEL BUDGET 800
Manufacturer
KARMA MEDICAL PRODUCTS CO., LTD.
Date Cleared
2006-10-04
(57 days)
Product Code
IOR
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
KARMA MEDICAL PRODUCTS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
Device Description
The KARMA Manual Wheelchair, Budget 800 is an indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The device can be disassembled for transport and it is foldable easily. Back upholstery material is also the same resistance-ignitability fabric.
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K Number
K041677Device Name
KARMA SCOOTER, MODEL KS-747.2
Manufacturer
KARMA MEDICAL PRODUCTS CO., LTD.
Date Cleared
2004-08-05
(45 days)
Product Code
INI
Regulation Number
890.3800Why did this record match?
Applicant Name (Manufacturer) :
KARMA MEDICAL PRODUCTS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
Device Description
The KARMA Scooter KS747.2 is an indoor / outdoor Powered Scooter that is battery operated. It has a base with four-wheeled with a seat. The movement of the Scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.
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K Number
K041678Device Name
KARMA POWER WHEELCHAIR, MODEL KP-25
Manufacturer
KARMA MEDICAL PRODUCTS CO., LTD.
Date Cleared
2004-07-23
(32 days)
Product Code
ITI
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
KARMA MEDICAL PRODUCTS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
Device Description
The KARMA Power Wheelchair, KP-25 is an indoor / outdoor Powered Wheelchair that is battery operated. It has a base with four-wheeled with a seat. The movement of the Wheelchair is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.
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