| ANSI AAMI NS4:2013(R)2017 Transcutaneous Electrical Nerve Stimulators |
| Recognition Number | Neurology |
| Recognition Date | 2019-01-14 |
| Recognition List | 051 |
| Recognition Number | 17-14 |
| Extent | Complete standard |
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| 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 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.
| Regulation Number | Device Name | Device Class | Product Code |
| §882.5890 | Stimulator, Nerve, Transcutaneous, For Pain Relief | Class 2 | GZJ |
| There is no relevant guidance developed at this time. |