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Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.
Classification. Class II.
This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.
This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].
It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.
§ 351 - Adulterated drugs and devices
§ 360 - Registration of producers of drugs or devices
§ 360c - Classification of devices intended for human use
§ 360e - Premarket approval
§ 360i - Records and reports on devices
§ 371 - Regulations and hearings
Title 21 published on 2015-04-01
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 874 after this date.
The Food and Drug Administration (FDA) is classifying the external upper esophageal sphincter (UES) compression 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 external UES compression 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.