FDA Classifies TENS for Congestion Relief as Class II Medical Device

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Rule

Medical Devices; Ear, Nose, and Throat Devices; Classification of the Transcutaneous Electrical Nerve Stimulator for the Relief of Congestion

A Rule by the Food and Drug Administration on 04/16/2026

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• Document Details Published Content - Document Details Agencies Department of Health and Human Services Food and Drug Administration Agency/Docket Number Docket No. FDA-2026-N-2959 CFR 21 CFR 874 Document Citation 91 FR 20348 Document Number 2026-07365 Document Type Rule Pages 20348-20350
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• Document Details Published Content - Document Details Agencies Department of Health and Human Services Food and Drug Administration Agency/Docket Number Docket No. FDA-2026-N-2959 CFR 21 CFR 874 Document Citation 91 FR 20348 Document Number 2026-07365 Document Type Rule Pages 20348-20350
  (3 pages) Publication Date 04/16/2026 Published Content - Document Details

• Document Dates Published Content - Document Dates Effective Date 2026-04-16 Dates Text This order is effective April 16, 2026. The classification was applicable on March 5, 2021. Published Content - Document Dates

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  • AGENCY:
  • ACTION:
  • SUMMARY:
  • DATES:
  • FOR FURTHER INFORMATION CONTACT:
  • SUPPLEMENTARY INFORMATION:
  • I. Background
  • II. De Novo Classification
  • III. Analysis of Environmental Impact
  • IV. Paperwork Reduction Act of 1995
  • List of Subjects in 21 CFR Part 874
  • PART 874—EAR, NOSE, AND THROAT DEVICES
  • Footnotes Enhanced Content - Table of Contents

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Department of Health and Human Services

Food and Drug Administration

1. 21 CFR Part 874
2. [Docket No. FDA-2026-N-2959]

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final amendment; final order.

SUMMARY:

The Food and Drug Administration (FDA, the Agency, or we) is classifying the transcutaneous electrical nerve stimulator for the relief of congestion into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the transcutaneous electrical nerve stimulator for the relief of congestion. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

DATES:

This order is effective April 16, 2026. The classification was applicable on March 5, 2021.

FOR FURTHER INFORMATION CONTACT:

Shu-Chen Peng, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1224, Silver Spring, MD 20993-0002, 301-796-6481, Shu-Chen.Peng@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

Upon request, FDA (the Agency or we) has classified the transcutaneous electrical nerve stimulator for the relief of congestion as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment.

The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (21 U.S.C. 360c(f)(1)). We refer to these devices as “postamendments devices” because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).

FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that does not require premarket approval. We determine whether a new device is substantially equivalent to a predicate device by means of the procedures for premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).

FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act (see also part 860, subpart D (21 CFR part 860, subpart D)). Section 207 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) established the first procedure for De Novo classification. Section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144) modified the De Novo application process by adding a second procedure. A device sponsor may utilize either procedure for De Novo classification.

Under the first procedure, the person submits a premarket notification (510(k)) for a device that has not previously been classified. After receiving an order from FDA classifying ( printed page 20349) the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2).

Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act.

Under either procedure for De Novo classification, FDA is required to classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically placed within class III, the De Novo classification is considered to be the initial classification of the device.

We believe this De Novo classification will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens. When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see section 513(f)(2)(B)(i) of the FD&C Act). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application to market a substantially equivalent device (see section 513(i) of the FD&C Act, defining “substantial equivalence”). Instead, sponsors can use the less burdensome 510(k) process, when necessary, to market their device.

II. De Novo Classification

On February 13, 2020, FDA received Tivic Health Systems Inc.'s request for De Novo classification of the ClearUP Sinus Relief device. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.

We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see section 513(a)(1)(B) of the FD&C Act). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device.

Therefore, on March 5, 2021, FDA issued an order to the requester classifying the device into class II. In this final order, FDA is codifying the classification of the device by adding 21 CFR 874.6000. [1 ] We have named the generic type of device “transcutaneous electrical nerve stimulator for the relief of congestion,” and it is identified as a device that electrically stimulates the skin overlying the paranasal sinuses to relieve congestion.

FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in table 1.

Identified risks to health	Mitigation measures
Injury from electrical current on face causing one or more of the following:

                         • Skin burn 
                         • Skin redness 
                         • Skin irritation 
                         • Facial muscle twitching 
                         • Electrical shock 
                         • Pain 
                         • Headache 
                         • Discomfort or muscle twitching of the eye | Non-clinical performance testing;
                         Human factors testing; 
                         Software verification, validation, and hazard analysis; 
                         Electrical safety testing; 
                         Electromagnetic compatibility testing; 
                         Battery safety testing; and 
                         Labeling. |

| Nerve and muscle injury | Non-clinical performance testing;
Electrical safety testing; and
Software verification, validation, and hazard analysis. |
| Ineffective treatment leading to worsening congestion | Labeling. |
FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this final order.

Under the FD&C Act, submission of a premarket notification under section 510(k) (21 U.S.C. 360(k)) is required to reasonably assure the safety and effectiveness of class II devices unless FDA determines that the device type should be exempt under section 510(m) of the FD&C Act. At this time FDA has not made this determination for the transcutaneous electrical nerve stimulator for the relief of congestion. This device is therefore subject to premarket notification requirements under section 510(k) of the FD&C Act.

III. Analysis of Environmental Impact

The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations and guidance. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in part 860, ( printed page 20350) subpart D, regarding De Novo classification have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval have been approved under OMB control number 0910-0231; the collections of information in part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 820 regarding quality management system regulation have been approved under OMB control number 0910-0073; and the collections of information in 21 CFR part 801, regarding labeling have been approved under OMB control number 0910-0485.

List of Subjects in 21 CFR Part 874

• Medical devices Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 874 is amended as follows:

PART 874—EAR, NOSE, AND THROAT DEVICES

1. The authority citation for part 874 continues to read as follows:

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

1. Add § 874.6000 to subpart F to read as follows:

§ 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.

Grace R. Graham,

Deputy Commissioner for Policy, Legislation, and International Affairs.

Footnotes

1.

                     FDA notes that the “ACTION” caption for this final order is styled as “Final amendment; final order,” rather than “Final order.” Beginning in December 2019, this editorial change was made to indicate that the document “amends” the Code of Federal Regulations. The change was made in accordance with the Office of Federal Register's (OFR) interpretations of the Federal Register Act ([44 U.S.C. chapter 15](https://www.govinfo.gov/link/uscode/44/1501)), its implementing regulations ([1 CFR 5.9](https://www.ecfr.gov/current/title-1/section-5.9) and [parts 21](https://www.ecfr.gov/current/title-1/part-parts21) and [22](https://www.ecfr.gov/current/title-1/part-22)), and the Document Drafting Handbook.

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Published Document: 2026-07365 (91 FR 20348)