||permanently mounted wheelchair platform lift|
||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.
||A permanently mounted wheelchair platform lift is a motorized vertical or inclined platform lift device permanently installed in one location.
||A permanently mounted guided platform to move a person with impaired mobility, with or without a wheelchair, from one level to another.
|Regulation Medical Specialty
|| Physical Medicine
Office of Device Evaluation
Division of Neurological and Physical Medicine Devices
Physical Medicine and Neurotherapueutic Devices Branch (PNDB)
|Total Product Life Cycle (TPLC)
TPLC Product Code Report
| 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