| 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 |
| Recognition Number | Neurology |
| Recognition Date | 2018-06-07 |
| Recognition List | 049 |
| Recognition Number | 17-16 |
| Extent | Complete standard |
| Standards Orgs | IEC International Electrotechnical Commission http://www.iec.ch/ |
| STG | Neurology |
| FDA Tech | Stephen Hinckley FDA/OMPT/CDRH/ODE/DNPMD/NSDP/ 301-796-6452 stephen.hinckley@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
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).
| 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 |
| 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. Guidance for Industry, FDA Reviewers/Staff and Compliance: Guidance Document for Powered Muscle Stimulator 510(k)s, Issued June 1999. |