---
kind: "section"
citation: "21 C.F.R. § 882.5888"
title: "21"
number: "882.5888"
heading: "Transcutaneous electrical nerve stimulator to treat fibromyalgia symptoms."
url: "https://uscodex.org/cfr/21/882.5888"
---

# §882.5888. Transcutaneous electrical nerve stimulator to treat fibromyalgia symptoms.

- (a) **Identification.** A transcutaneous electrical nerve stimulator to treat fibromyalgia symptoms is a prescription device that transcutaneously stimulates a patient's sensory nerves through electrodes placed on the skin to treat fibromyalgia symptoms.
- (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. This testing must include:
    - (i) **Characterization of the electrical stimulation parameters, including the following—** waveforms; output modes; maximum output voltage and maximum output current (at 500Ω, 2kΩ, and 10kΩ loads); pulse duration; frequency; net charge per pulse; maximum phase charge, maximum current density, maximum average current, and maximum average power density (at 500Ω);
    - (ii) Characterization of the impedance monitoring system; and
    - (iii) Characterization of electrode performance, including the electrical performance, adhesive integrity, shelf life, reusability, and current distribution of the electrode surface area.
  - (2) The patient-contacting components of the device must be demonstrated to be biocompatible.
  - (3) Performance testing must demonstrate electrical, thermal, and mechanical safety along with electromagnetic compatibility of the device in the intended use environment.
  - (4) Software verification, validation, and hazard analysis must be performed.
  - (5) Labeling must include the following:
    - (i) Recommended treatment regimes, including but not limited to, frequency and duration of use, application site(s), and typical sensations experienced during treatment;
    - (ii) A shelf life for the electrode and reuse information;
    - (iii) Summaries of the electrical stimulation parameters and device technical parameters (including any wireless specifications); and
    - (iv) **Instructions on how to correctly use and maintain the device, including all user-interface components.**

## Notes

### Amendments

[91 FR 31897, May 29, 2026]

### Authority

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

### Source

Source: 44 FR 51730, Sept. 4, 1979, unless otherwise noted.

### Amendments

[91 FR 31897, May 29, 2026]