# Sensus Se-SK4

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/sensus-se-sk4>
- Manufacturer: [Neurometrix, Inc.](https://devicerts.com/manufacturers/neurometrix-inc) (United States, FDA 510(k) applicant)
- Name in the registry: SENSUS SE-SK4
- Device class: Class II (US FDA)
- FDA product code: NUH, GZJ
- GMDN: Analgesic transcutaneous electrical nerve stimulation system (35372)

## Registrations and authorizations

- **GUDID** · GUDID listing · United States · UDI-DI 00851221006322 · listed 2016-09-09 · status: Listed (GUDID: not in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K130919 · decision 2013-07-02 · decision SESE · status: Active · from GUDID

## Recalls

No recall on record.

## Identity

- Trade name: SENSUS [FDA GUDID (AccessGUDID)]
- Generic name: Analgesic transcutaneous electrical nerve stimulation system [FDA GUDID (AccessGUDID)]
- Model / reference: SE-SK4 [FDA GUDID (AccessGUDID)]
- Description: SENSUS System Kit, 2 Devices (Includes 2 SE-S01) 2 SE-001 and 2 SE-S01 or QE-P01 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 00851221006322 [FDA GUDID (AccessGUDID)]
- FDA product code: NUH [FDA GUDID (AccessGUDID)]
- GMDN term: Analgesic transcutaneous electrical nerve stimulation system (35372) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 882.5890 [FDA GUDID (AccessGUDID)]
- GUDID distribution status: Not in Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Convenience kit: Yes [FDA GUDID (AccessGUDID)]
- Lot / batch number: Yes [FDA GUDID (AccessGUDID)]
- Serial number: Yes [FDA GUDID (AccessGUDID)]
- Expiration date: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [FDA GUDID (AccessGUDID)]
- Sterilise before use: No [FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [FDA GUDID (AccessGUDID)]
- Contains latex: No [FDA GUDID (AccessGUDID)]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: Sensus Se-SK4, Neurometrix, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/sensus-se-sk4 (data as of 2026-11-15).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/sensus-se-sk4.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/sensus-se-sk4
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.