Stimulator, Electrical, Transcutaneous, For Arthritis
The Stimulator, Electrical, Transcutaneous, For Arthritis (product code NYN) is a transcutaneous electrical stimulation device that applies an electrical current through cutaneous electrodes on a patient's skin to provide relief of pain associated with arthritis, including osteoarthritis and rheumatoid arthritis. It is classified as FDA Class 2, requiring 510(k) clearance, and is regulated under 21 CFR 882.5890 within the Neurology specialty. Third-party 510(k) review is available, and the device carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- NYN
- Device Class
- FDA class 2
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
Definition
Electrical stimulation unit with leads and cutaneous electrodes used to apply an electrical current through electrodes on patient's skin to provide relief of pain associated with arthritis (including osteoarthritis and rheumatoid arthritis).
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K142236 | BioniCare Hand System | Mar 23, 2015 | Substantially Equivalent | Vision Quest Industries, Inc. |
| K111557 | X-FORCE | Nov 10, 2011 | Substantially Equivalent | Seven Seas Distribtion and Manufacturing, LLC |
| K073386 | JOINT STIM, MODEL 1000 | Jul 30, 2008 | Substantially Equivalent | Pain Management Technologies |
| K062325 | RS-4I MUSCLE STIMULATOR FAMILY | Apr 13, 2007 | Substantially Equivalent | Rs Medical |
| K052625 | BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000 | Dec 05, 2005 | Substantially Equivalent | Bionicare Medical Technologies, Inc. |
| K030332 | MODIFICATION TO BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000 | Jun 06, 2003 | Substantially Equivalent | Bionicare Medical Technologies, Inc. |
| K983228 | BIONICARE STIMILATOR SYSTEM, MODEL BIO-1000 | Mar 15, 1999 | Substantially Equivalent | Murray Electronics |
| K971437 | BIONICARE STIMULATOR SYSTEM. MODEL BIO-1000 | Jul 22, 1997 | Substantially Equivalent | Murray Electronics |
FEI Numbers
This FDA classification entry is associated with 66 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 66 registration numbers. Click on an entry to view related FDA registrations.