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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 051 Date of Entry 01/14/2019 
FR Recognition Number 17-14
Standard
ANSI AAMI NS4:2013(R)2017 Transcutaneous Electrical Nerve Stimulators
Scope/Abstract
This standard establishes labeling, safety, and performance requirements and referee tests for transcutaneous electrical stimulators (including TENS) intended for use in the treatment of pain syndrome. Also covered are labeling requirements for patient leads and electrodes.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§882.5890 Stimulator, Nerve, Transcutaneous, For Pain Relief Class 2 GZJ
FDA Technical Contact
 Stephen Hinckley
  FDA/OC/CDRH/OPEQ/OHTV/DHTVB/
  301-796-6452
  stephen.hinckley@fda.hhs.gov
Standards Development Organizations
AAMI Association for the Advancement of Medical Instrumentation http://www.aami.org
ANSI American National Standards Institute https://www.ansi.org/
FDA Specialty Task Group (STG)
Neurology
*These are provided as examples and others may be applicable.
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