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Zdrowie i gospodarka · 12/06/2015

Medical Devices; Exemption From Premarket Notification: Electric Positioning Chair

The Food and Drug Administration (FDA) is announcing that it has received a petition requesting exemption from the premarket notification requirements for an electric positioning chair with a motorized positioning control that is intended for medical purposes and that can be adjusted to various positions. The device is used to provide stability for patients with athetosis (involuntary spasms) and to alter postural positions. 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 →