NYN · Stimulator, Electrical, Transcutaneous, For Arthritis
Neurology · 21 CFR 882.5890 · Class 2
Overview
| Product Code | NYN |
|---|---|
| Device Name | Stimulator, Electrical, Transcutaneous, For Arthritis |
| Regulation | 21 CFR 882.5890 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 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 | BioniCare Hand System | Vision Quest Industries, Inc. | Mar 23, 2015 | SESE |
| K111557 | X-FORCE | Seven Seas Distribtion and Manufacturing, LLC | Nov 10, 2011 | SESE |
| K073386 | JOINT STIM, MODEL 1000 | Pain Management Technologies | Jul 30, 2008 | SESE |
| K062325 | RS-4I MUSCLE STIMULATOR FAMILY | Rs Medical | Apr 13, 2007 | SESE |
| K052625 | BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000 | Bionicare Medical Technologies, Inc. | Dec 5, 2005 | SESE |
| K030332 | MODIFICATION TO BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000 | Bionicare Medical Technologies, Inc. | Jun 6, 2003 | SESE |
| K983228 | BIONICARE STIMILATOR SYSTEM, MODEL BIO-1000 | Murray Electronics | Mar 15, 1999 | SESE |
| K971437 | 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
