Recognized standard
NS4:2013(R)2017
FDA recognition 17-14 · ANSI · Neurology
Key facts
| Recognition number | 17-14 |
|---|---|
| Designation | NS4:2013(R)2017 |
| Title | Transcutaneous Electrical Nerve Stimulators |
| Standards developer | American National Standards Institute |
| Specialty area | Neurology |
| Date of entry | Jan 14, 2019 |
| Device classes | Class 2 |
| Scope (excerpt) | 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. |
At a glance
- 1–9 Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: