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Found 3 results
510(k) Data Aggregation
K Number
K151199Device Name
SmartDrive Wheelchair Power Assist
Manufacturer
MAX MOBILITY, LLC
Date Cleared
2015-07-30
(86 days)
Product Code
ITI
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
MAX MOBILITY, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SmartDrive MX2 Wheelchair Power Assist is intended to provide auxiliary power to manual wheelchairs to reduce the pushing power needed by their users, including pediatrics. It is intended to be used by users capable of operating and maneuvering a powered and manual wheelchair.
Device Description
SmartDrive MX2 Wheelchair Power Assist
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K Number
K113621Device Name
SMARTDRIVE WHEELCHAIR POWER-ASSIST
Manufacturer
MAX MOBILITY, LLC
Date Cleared
2012-07-06
(211 days)
Product Code
ITI
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
MAX MOBILITY, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SmartDrive is intended to provide power-assist to manual wheelchairs, empowering disabled persons, including pediatrics, capable of operating a powered and manual wheelchair by providing a means of enhanced mobility.
Device Description
Not Found
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K Number
K102837Device Name
HIROLLER ELEVATING WHEELCHAIR
Manufacturer
MAX MOBILITY, LLC
Date Cleared
2010-12-23
(85 days)
Product Code
IPL
Regulation Number
890.3900Why did this record match?
Applicant Name (Manufacturer) :
MAX MOBILITY, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HiRoller Elevating Wheelchair is a product that allows wheelchair users to raise and lower their seat height while seated in the wheelchair.
Device Description
Not Found
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