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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 049 Date of Entry 06/07/2018 
FR Recognition Number 17-16
Standard(Included in ASCA)
IEC  60601-2-10 Edition 2.1 2016-04
Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
Scope/Abstract
This international standard specifies the requirements for the safety of nerve and muscle stimulators defined in sub clause 2 01.3.204, for use in the practice of physical medicine, hereinafter referred to as ME equipment. This includes transcutaneous electrical nerve stimulators (TENS) and electrical muscle stimulators (EMS).
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
§890.5850 Stimulator, Muscle, Powered Class 2 IPF
§890.5850 Stimulator, Muscle, Powered, For Muscle Conditioning Class 2 NGX
§890.5850 Stimulator, Muscle, Powered, Dental Class 2 NUW
§890.5850 Stimulator, Muscle, Powered, With Limited Output, For Rehabilitation Class 2 NYY
§890.5850 Stimulator, Muscle, Powered, With Limited Output, For Muscle Conditioning Class 2 NYZ
Relevant FDA Guidance and/or Supportive Publications*
1. AAMI CR500:2019 Basic Introduction to the IEC 60601 Series.

2. For Industry and FDA Staff: Guidance on Electrosurgical Devices and the Application of the Performance Standard for Electrode Lead Wires and Patient Cables, Issued November 1999.

3. Guidance for Industry, FDA Reviewers/Staff and Compliance: Guidance Document for Powered Muscle Stimulator 510(k)s, Issued June 1999.


Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Stephen Hinckley
  FDA/OC/CDRH/OPEQ/OHTV/DHTVB/
  301-796-6452
  stephen.hinckley@fda.hhs.gov
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
Neurology
*These are provided as examples and others may be applicable.
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