---
kind: "section"
citation: "21 C.F.R. § 874.5950"
title: "21"
number: "874.5950"
heading: "Oropharyngeal electrical stimulator."
url: "https://uscodex.org/cfr/21/874.5950"
---

# §874.5950. Oropharyngeal electrical stimulator.

- (a) **Identification.** An oropharyngeal electrical stimulator is a device that stimulates afferent nerve fibers of oropharyngeal mucosa. The device is intended to treat swallowing dysfunction. The device may incorporate a feeding tube.
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (1) Non-clinical performance testing must demonstrate the device performs as intended under anticipated conditions of use, including the following:
    - (i) Electrical output testing;
    - (ii) Mechanical integrity testing of electrical components;
    - (iii) Testing to verify safe use of the electrical stimulator component in the presence of supplementary oxygen; and
    - (iv) If the device incorporates a feeding tube, feeding tube functionality testing, including mechanical integrity, liquid leakage, flow rate and connector compatibility.
  - (2) The patient-contacting components of the device must be demonstrated to be biocompatible.
  - (3) Performance testing must demonstrate the sterility of the components intended to be provided sterile.
  - (4) Performance data must validate the reprocessing instructions for any reusable components of the device.
  - (5) Performance testing must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the labeled shelf life.
  - (6) Software verification, validation and hazard analysis must be performed for any software components of the device.
  - (7) Performance testing must demonstrate the electromagnetic compatibility and electrical safety of any electrical components.
  - (8) A training program must be included with sufficient educational elements so that upon completion of the training program, the user can correctly operate the device.
  - (9) Usability testing must demonstrate that the device can be correctly used as per training and labeling.
  - (10) The labeling must include a shelf life for any sterile components.

## Notes

### Amendments

[91 FR 32346, June 1, 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 32346, June 1, 2026]