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Self-Injurious Behavior Inhibiting System / Aversives / Medical device / Judge Rotenberg Educational Center / Center for Devices and Radiological Health / Federal Food /  Drug /  and Cosmetic Act / Aversion therapy / Medicine / Health / Food and Drug Administration


FDA Executive Summary Prepared for the April 24, 2014 meeting of the Neurological Devices Panel Electrical Stimulation Devices for Aversive Conditioning
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Company

SIBIS [Self-Injurious Behavior Inhibiting System] Oxford Medilog Inc. / Farrall Instruments Inc. / /

Country

United States / Israel / /

Event

FDA Phase / /

IndustryTerm

electrical stimulation devices / ban to devices / to these devices / federal law / device / aversive conditioning devices / device technology / predicate device / prescription devices / modified devices / cleared devices / aversive conditioning device / /

MedicalCondition

Developmental Disabilities / aversive shock / chronic physical damage / shock / Patient injury / pain / injury / intellectual and developmental disabilities / illness / actual injury / electrical shock / /

Organization

National Institute of Health / Center for Devices and Radiological Health / office of Compliance / FDA Authority / Judge Rotenberg Center / FDA / Persons Protection Committee / Massachusetts Department of Developmental Services / New York State Education Department / Judge Rotenberg Educational Center / Council on Scientific Affairs / Medical Device Advisory Committee / /

Position

Executive / /

Product

ESDs / K760166 / /

ProvinceOrState

Massachusetts / /

Technology

device technology / /

SocialTag