---
kind: "section"
citation: "21 C.F.R. § 876.5026"
title: "21"
number: "876.5026"
heading: "Non-implanted electrical stimulation device for management of premature ejaculation."
url: "https://uscodex.org/cfr/21/876.5026"
---

# §876.5026. Non-implanted electrical stimulation device for management of premature ejaculation.

- (a) **Identification.** A non-implanted electrical stimulation device for management of premature ejaculation is intended to be used in patients with premature ejaculation by delivery of electrical stimulation to the perineal muscles and nerves.
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (1) The device must be demonstrated to be biocompatible.
  - (2) Performance testing must demonstrate the electromagnetic compatibility, electrical safety, and thermal safety of the device.
  - (3) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
    - (i) Mechanical performance;
    - (ii) Electrical stimulation parameters; and
    - (iii) **Battery performance.**
  - (4) Performance testing must support shelf life by demonstrating continued device functionality over the identified shelf life.
  - (5) Software verification, validation, and hazard analysis must be performed.
  - (6) Labeling must include:
    - (i) Specific instructions regarding safe placement and correct use of the device;
    - (ii) Warning(s) against use by patients with active implanted medical devices; and
    - (iii) **A shelf life.**

## Notes

### Amendments

[87 FR 34166, Apr. 5, 2022]

### Authority

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

### Source

Source: 48 FR 53023, Nov. 23, 1983, unless otherwise noted.

### Amendments

[87 FR 34166, Apr. 5, 2022]