---
kind: "section"
citation: "21 C.F.R. § 874.6000"
title: "21"
number: "874.6000"
heading: "Transcutaneous electrical nerve stimulator for the relief of congestion."
url: "https://uscodex.org/cfr/21/874.6000"
---

# §874.6000. Transcutaneous electrical nerve stimulator for the relief of congestion.

- (a) **Identification.** A transcutaneous electrical nerve stimulator for the relief of congestion is a device that electrically stimulates the skin overlying the paranasal sinuses to relieve congestion.
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including electrical stimulation parameters that must be specified and verified.
  - (2) Performance data must demonstrate the electromagnetic compatibility, battery safety, and electrical safety of the device.
  - (3) Software verification, validation, and hazard analysis must be performed.
  - (4) The patient-contacting components of the device must be demonstrated to be biocompatible.
  - (5) Human factors testing must demonstrate that users can successfully use the device in the intended use environment based solely on its labeling and instructions for use.
  - (6) Labeling must include the following:
    - (i) Instructions for use, including images that demonstrate how to use the device;
    - (ii) Device specifications, including the number of channels, output waveform, stimulation peak voltage and current, pulse duration, frequency, maximum current density, maximum phase charge, and power source; and
    - (iii) **Explanations of the user-interface components.**

## Notes

### Amendments

[91 FR 20350, Apr. 16, 2026]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 51 FR 40389, Nov. 6, 1986, unless otherwise noted.

### Amendments

[91 FR 20350, Apr. 16, 2026]