Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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049
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Date of Entry 06/07/2018
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FR Recognition Number
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17-16
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Standard | (Included in ASCA pilot) |
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 |
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Scope/AbstractThis 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). |
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Extent of Recognition
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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. |
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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, Dental |
Class 2 |
NUW |
§890.5850 |
Stimulator, Muscle, Powered, For Muscle Conditioning |
Class 2 |
NGX |
§890.5850 |
Stimulator, Muscle, Powered, With Limited Output, For Muscle Conditioning |
Class 2 |
NYZ |
§890.5850 |
Stimulator, Muscle, Powered, With Limited Output, For Rehabilitation |
Class 2 |
NYY |
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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. |
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FDA Technical Contact
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Standards Development Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |