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Zdrowie i gospodarka · 18.06.2014

Medical Devices; Exemption From Premarket Notification: Wheelchair Elevator

The Food and Drug Administration (FDA) is announcing that it has received a petition requesting exemption from the premarket notification requirements for a wheelchair elevator device commonly known as a manually operated portable wheelchair lift. This device is used to provide a means for a disabled person to move a wheelchair from one level to another. FDA is publishing this notice to obtain comments in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA).

Source: Federal Register — Food and Drug AdministrationOpen original release →