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510(k) Data Aggregation
K Number
K192885Device Name
C.T.M. Mobility Scooter HS-268
Manufacturer
Chien Ti Enterprise Co., Ltd.
Date Cleared
2019-12-09
(60 days)
Product Code
INI
Regulation Number
890.3800Why did this record match?
Applicant Name (Manufacturer) :
Chien Ti Enterprise Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The C.T.M. Mobility Scooter HS-268 is an indoor/outdoor scooter that provides transportation for a disabled or elderly person in age of 16 up to 85 year old.
Device Description
The C.T.M. Mobility Scooter HS-268 is an indoor/outdoor scooter that is powered by 25.2Vdc, 11000mAh, 277.2Wh (min) and 25.2Vdc, 11600mAh, 292.32Wh (typ) Lithium battery, equipped with four wheels, capacity of 253.5 lbs and a lightweight seat. It's a rear wheel drive scooter with theoretical driving ranges of 9.3 miles. 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 folded/unfolded and is provided with an off-board battery charger. The maximum speed is 5 mph.
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K Number
K181344Device Name
C.T.M Mobility Scooter
Manufacturer
CHIEN TI ENTERPRISE CO., LTD.
Date Cleared
2018-12-14
(207 days)
Product Code
INI
Regulation Number
890.3800Why did this record match?
Applicant Name (Manufacturer) :
CHIEN TI ENTERPRISE CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The C.T.M. Mobility Scooter HS-115 in an indoor/outdoor scooter that provides transportation for a disabled or elderly person.
Device Description
The C.T.M. Mobility Scooter HS-115 is an indoor/outdoor scooter that is powered by two 12Ah lead-acid batteries, equipped with three wheels, capacity of 115 kilograms and a lightweight adjustable seat. It's a rear wheel drive scooter with theoretical driving ranges of 10 kilometer. 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 off-board battery charger. The maximum speed is 4 m.p.h.
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K Number
K162952Device Name
C.T.M. Mobility Scooter
Manufacturer
CHIEN TI ENTERPRISE CO., LTD.
Date Cleared
2017-05-03
(191 days)
Product Code
INI
Regulation Number
890.3800Why did this record match?
Applicant Name (Manufacturer) :
CHIEN TI ENTERPRISE CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The C.T.M. Mobility Scooter HS-328 in an indoor/outdoor scooter that provides transportation for a disabled or elderly person.
Device Description
The C.T.M. Mobility Scooter HS-328 is an indoor/outdoor scooter that is powered by two 22Ah lead-acid batteries, equipped with four pneumatic wheels, capacity of 136 kilograms and a lightweight adjustable seat. It a rear wheel drive scooter with theoretical driving ranges of 17.5 kilometer. 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 off-board battery charger.
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