| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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064
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Date of Entry 05/26/2025
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FR Recognition Number
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17-22
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| Standard | (Included in ASCA) |
IEC 60601-2-10 Edition 2.2 2023-01 CONSOLIDATED VERSION
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/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). |
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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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Transition Period
| FDA recognition of IEC 60601-2-10 Edition 2.1 2016-04 [Rec# 17-16] will be superseded by recognition of IEC 60601-2-10 Edition 2.2 2023-01 [Rec# 17-22]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 17-16] until July 2, 2028. After this transition period, declarations of conformity to [Rec# 17-16] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| 882.1871 |
Neuromuscular Stimulator And Exercise Evaluation System
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Class 2
|
SDX
|
| §882.5890 |
Stimulator, Nerve, Transcutaneous, For Pain Relief
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Class 2
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GZJ
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| §882.5890 |
Interferential Current Therapy
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Class 2
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LIH
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| §882.5890 |
Stimulator, Nerve, Transcutaneous, Over-The-Counter
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Class 2
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NUH
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| §882.5890 |
Stimulator, Electrical, Transcutaneous, For Arthritis
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Class 2
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NYN
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| §890.5850 |
Stimulator, Muscle, Powered
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Class 2
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IPF
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| §890.5850 |
Stimulator, Muscle, Powered, For Muscle Conditioning
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Class 2
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NGX
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| §890.5850 |
Stimulator, Muscle, Powered, Dental
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Class 2
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NUW
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| §890.5850 |
Stimulator, Muscle, Powered, With Limited Output, For Rehabilitation
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Class 2
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NYY
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| §890.5850 |
Stimulator, Muscle, Powered, With Limited Output, For Muscle Conditioning
|
Class 2
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NYZ
|
| 890.5851 |
Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation
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Class 2
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SDO
|
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Relevant FDA Guidance and/or Supportive Publications*
1. AAMI CR500:2019 Basic Introduction to the IEC 60601 Series.
2. Guidance on Electrosurgical Devices and the Application of the Performance Standard for Electrode Lead Wires and Patient Cables, Guidance for Industry and FDA Staff, issued November 1999.
3. Guidance Document for Powered Muscle Stimulator 510(k)s, Guidance for Industry, FDA Reviewers/Staff and Compliance, 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. |
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