Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart F — Neurological Therapeutic Devices](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices) → [21 CFR 882.5890](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5890) → OCF — Stimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief

# OCF · Stimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief

_Neurology · 21 CFR 882.5890 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/OCF

## Overview

- **Product Code:** OCF
- **Device Name:** Stimulator, Nerve, Electrical, Transcutaneous, Limited Output, Arthritis Pain Relief
- **Regulation:** [21 CFR 882.5890](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5890)
- **Device Class:** 2
- **Review Panel:** [Neurology](/submissions/NE)
- **3rd-party reviewable:** yes

## Identification

A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K900759](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/OCF/K900759.md) | POLY-OP (TM) | Nu-Gyn-Tek, Inc. | May 24, 1990 | SESE |

## Top Applicants

- Nu-Gyn-Tek, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/OCF](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/OCF)

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