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510(k) Data Aggregation
K Number
K122562Device Name
E-TENG MODEL EOR 1
Manufacturer
Date Cleared
2013-08-09
(352 days)
Product Code
Regulation Number
890.3900Why did this record match?
Applicant Name (Manufacturer) :
E-TENG TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The device is a product which changes people's position from standing to sitting or sitting to standing and any position in between. The product provides indoor and outdoor mobility on surfaces like tar, grass and gravel. However, it should not be driven in the standing position on uneven ground.
Device Description
The device changes people's position in/from seating or/to standing but also any position in between. It provides indoor and outdoor mobility on surfaces like tar, grass and gravel. However, it is not allowed to drive in standing position on uneven ground. The device is powered by a 24 V DC/36 Ah, lead-acid battery, approximate driving range on fully charged battery is up to 32 km(19 miles), depending on use and the terrain the wheelchair is driven on, and which maximum speed is up to 8 km/h (5 mph). The device is middle wheels with motors driven and controlled by the DYNAMIC DX2 controller.
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