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510(k) Data Aggregation
K Number
K242430Device Name
Power-Flex (PFX1214); Power-Flex (PFX1517); Power-Flex (PFX1820)
Manufacturer
Date Cleared
2024-11-12
(89 days)
Product Code
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
Soul Mobility
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Power-Flex by Soul Mobility is intended to provide enhanced mobility to disabled persons who are capable of operating a powered and manual wheelchair, by providing powered mobility to manual wheelchairs.
Device Description
Power-Flex is a power-assist drive that can be attached to a manual wheelchair frame, which enables a manual wheelchair to perform like an electrical wheelchair. The Power-Flex drive system includes two drive wheels, two caster wheels for stability, batteries, a control unit, a power supply and a manual tilt mechanism which also acts as an anti-tip preventative. The Power-Flex connects via the manual chair frame standard axle receivers and the rear manual tilt clamp which attaches to the rear rigidizer bar of the manual wheelchair. The manual wheelchair and frame are not part of the drive system and is provided by the customer. The control unit is the steering device of the system
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