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U.S. Department of Health and Human Services

Product Classification

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Device permanently mounted wheelchair platform lift
Regulation Description Wheelchair elevator.
Definition Intended for medical purposes to provide a guided platform to move a person with impaired mobility, with or without a wheelchair, from one level to another.
Physical State A permanently mounted wheelchair platform lift is a motorized vertical or inclined platform lift device permanently installed in one location.
Technical Method A permanently mounted guided platform to move a person with impaired mobility, with or without a wheelchair, from one level to another.
Target Area n/a
Regulation Medical Specialty Physical Medicine
Review Panel Physical Medicine
Product CodePCE
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Physical Medicine and Neurotherapueutic Devices Branch (PNDB)
Submission Type 510(K) Exempt
Regulation Number 890.3930
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
    Note: Class II devices the Food and Drug Administration (FDA) has also published a list of Class II (special controls) devices subject to certain limitations, that are now exempt from the premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). FDA believes that these exemptions will relieve manufacturers from the need to submit premarket notification submissions for these devices and will enable FDA to redirect the resources that would be spent on reviewing such submissions to more significant public health issues. FDA is taking this action in order to meet a requirement of the Modernization Act.
Third Party Review Not Third Party Eligible
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