section_subject: "Limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites."
cfr_reference: "21 CFR 882.5894"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 800 to 1299"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(a)Identification. A limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites is a device intended to alleviate skin reactions associated with insect bites via cutaneous, piezoelectric stimulation at the local site of the bite.
(b)Classification. Class II (special controls). The special controls for this device are:
(1)Appropriate testing to characterize the electrical output specifications of the device (i.e., total charge delivered, maximum instantaneous output current, maximum instantaneous output voltage, pulse duration, charge density) must be conducted.
(2)Mechanical bench testing must demonstrate that the device will withstand the labeled number duration of uses.
(3)All elements of the device that may contact the patient must be assessed to be biocompatible.