(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.