FDA product code NYN: Stimulator, Electrical, Transcutaneous, For Arthritis
NYN is the FDA product code for stimulator, electrical, transcutaneous, for arthritis. It is a Class II device, regulated under 21 CFR 882.5890 and reviewed by the Neurology panel. FDA has cleared 8 510(k) submissions under NYN, from 6 different applicants. The average 510(k) review took 168 days (median 170).
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).
Classification
| Field | Value |
|---|---|
| Device name | Stimulator, Electrical, Transcutaneous, For Arthritis |
| Device class | Class II |
| Regulation | 21 CFR 882.5890 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every NYN clearance
Top NYN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bionicare Medical Technologies, Inc. | 2 | 2005-12-05 |
| Murray Electronics | 2 | 1999-03-15 |
| Vision Quest Industries, Inc. | 1 | 2015-03-23 |
| Seven Seas Distribtion and Manufacturing, LLC | 1 | 2011-11-10 |
| Pain Management Technologies | 1 | 2008-07-30 |
1 more applicants have NYN clearances. See the full list in Caduvo.
Most recent NYN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K142236 | Vision Quest Industries, Inc. | BioniCare Hand System | 2015-03-23 | 222 |
| K111557 | Seven Seas Distribtion and Manufacturing, LLC | X-FORCE | 2011-11-10 | 160 |
| K073386 | Pain Management Technologies | JOINT STIM, MODEL 1000 | 2008-07-30 | 240 |
| K062325 | Rs Medical | RS-4I MUSCLE STIMULATOR FAMILY | 2007-04-13 | 247 |
| K052625 | Bionicare Medical Technologies, Inc. | BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000 | 2005-12-05 | 73 |
Recalls for NYN devices
openFDA lists no recalls for product code NYN.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- L8678 — Electrical stimulator supplies (external) for use with implantable neurostimulator, per month
Frequently asked questions
What is FDA product code NYN?
NYN is the FDA product code for stimulator, electrical, transcutaneous, for arthritis. It is a Class II device, regulated under 21 CFR 882.5890 and reviewed by the Neurology panel.
What device class is NYN?
Class II, regulation 21 CFR 882.5890. Typical premarket route: 510(k).
How long does a 510(k) take for product code NYN?
Across 8 cleared submissions the average was 168 days from receipt to decision (median 170).
Which companies have the most NYN clearances?
Bionicare Medical Technologies, Inc. (2); Murray Electronics (2); Vision Quest Industries, Inc. (1); Seven Seas Distribtion and Manufacturing, LLC (1); Pain Management Technologies (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NYN
- Run a recall and safety report across every NYN manufacturer
- Watch product code NYN for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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