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Medical Devices; Neurological Devices, Classification of the Vibratory Counter-Stimulation Device. Final order.

出版信息

Fed Regist. 2017 Mar 14;82(48):13553-4.

PMID:28355048
Abstract

The Food and Drug Administration (FDA) is classifying the vibratory counter-stimulation device into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the vibratory counter-stimulation device's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

摘要

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