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) → NYN — Stimulator, Electrical, Transcutaneous, For Arthritis

# NYN · Stimulator, Electrical, Transcutaneous, For Arthritis

_Neurology · 21 CFR 882.5890 · Class 2_

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

## Overview

- **Product Code:** NYN
- **Device Name:** Stimulator, Electrical, Transcutaneous, For Arthritis
- **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 (8 of 8)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K142236](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NYN/K142236.md) | BioniCare Hand System | Vision Quest Industries, Inc. | Mar 23, 2015 | SESE |
| [K111557](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NYN/K111557.md) | X-FORCE | Seven Seas Distribtion and Manufacturing, LLC | Nov 10, 2011 | SESE |
| [K073386](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NYN/K073386.md) | JOINT STIM, MODEL 1000 | Pain Management Technologies | Jul 30, 2008 | SESE |
| [K062325](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NYN/K062325.md) | RS-4I MUSCLE STIMULATOR FAMILY | Rs Medical | Apr 13, 2007 | SESE |
| [K052625](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NYN/K052625.md) | BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000 | Bionicare Medical Technologies, Inc. | Dec 5, 2005 | SESE |
| [K030332](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NYN/K030332.md) | MODIFICATION TO BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000 | Bionicare Medical Technologies, Inc. | Jun 6, 2003 | SESE |
| [K983228](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NYN/K983228.md) | BIONICARE STIMILATOR SYSTEM, MODEL BIO-1000 | Murray Electronics | Mar 15, 1999 | SESE |
| [K971437](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/NYN/K971437.md) | BIONICARE STIMULATOR SYSTEM. MODEL BIO-1000 | Murray Electronics | Jul 22, 1997 | SESE |

## Top Applicants

- Bionicare Medical Technologies, Inc. — 2 clearances
- Murray Electronics — 2 clearances
- Pain Management Technologies — 1 clearance
- Rs Medical — 1 clearance
- Seven Seas Distribtion and Manufacturing, LLC — 1 clearance

---

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

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com