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510(k) Data Aggregation
K Number
K243970Device Name
Portable Wheelchair
Manufacturer
Intradin (Shanghai) Machinery Co., Ltd
Date Cleared
2025-03-07
(74 days)
Product Code
ITI
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
Intradin (Shanghai) Machinery Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
Device Description
Portable Wheelchair
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K Number
K250027Device Name
Powered Mobility Scooter
Manufacturer
Intradin (Shanghai) Machinery Co., Ltd
Date Cleared
2025-02-21
(46 days)
Product Code
INI
Regulation Number
890.3800Why did this record match?
Applicant Name (Manufacturer) :
Intradin (Shanghai) Machinery Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Powered Mobility scooteris intended for medical purposes to provide mobility to persons restricted to a sitting position.
Device Description
Powered Mobility Scooter
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K Number
K232692Device Name
Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GUT140)
Manufacturer
Intradin (Shanghai) Machinery Co., Ltd
Date Cleared
2024-09-05
(366 days)
Product Code
INI
Regulation Number
890.3800Why did this record match?
Applicant Name (Manufacturer) :
Intradin (Shanghai) Machinery Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Powered Mobility Scooter is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Device Description
The Powered Mobility Scooter. Models: PMS101. GUT112, is a battery powered three wheeled scooter intended to provide mobility for elderly or disabled individuals in a variety of indoor and outdoor settings. It consists lithium battery with an off-board battery charger, Handle-bar, Brake, Seat, Back support, Frame, One Front wheel and Two Rear wheels. The scooter controlled through a thumb throttle. The left brake handle is controlled mechanical brake which lock the drum brake in the right rear wheel. When actuated brake handle, it will stop scooter and cut power supply to the motor .It has a driving range of 15.6 km between charges. It is capable of carrying a driver weighing up to 125 kg.
The Powered Mobility Scooter, Models: PMS103, GUT140, is a battery powered three wheeled scooter intended to provide mobility for elderly or disabled individuals in a variety of indoor and outdoor settings. It consists lithium battery with an off-board battery charger, Handle-bar, Brake, Seat, Back support, Frame, Armrest, One Front wheel and Two Rear wheels. The scooter controlled through a thumb throttle. The left brake handle is controlled mechanical brake which lock the drum brake in the right rear wheel. When actuated brake handle, it will stop scooter and cut power supply to the motor. It has a driving range of 10.4 km between charges. It is capable of carrying a driver weighing up to 125 kg.
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