K213188 is an FDA 510(k) clearance for the Primary Relief. This device is classified as a Stimulator, Nerve, Electrical, Percutaneous (pens), For Pain Relief (Class II - Special Controls, product code NHI).
Submitted by Dyansys, Inc. (San Mateo, US). The FDA issued a Cleared decision on January 31, 2022, 124 days after receiving the submission on September 29, 2021.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5890. Percutaneous Electrical Nerve Stimulator (pens) Is A Device Used For The Treatment Of Pain. Unlike The Classified Transcutaneous Electrical Nerve Stimulator That Apply An Electrical Current To Electrodes On A Patient's Skin To Deliver Stimulation, A Pens Uses Electrodes That Are Placed Percutaneously To Deliver Stimulation,.
| 510(k) Number | K213188 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2021 |
| Decision Date | January 31, 2022 |
| Days to Decision | 124 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | NHI - Stimulator, Nerve, Electrical, Percutaneous (pens), For Pain Relief |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5890 |
| Definition | Percutaneous Electrical Nerve Stimulator (pens) Is A Device Used For The Treatment Of Pain. Unlike The Classified Transcutaneous Electrical Nerve Stimulator That Apply An Electrical Current To Electrodes On A Patient's Skin To Deliver Stimulation, A Pens Uses Electrodes That Are Placed Percutaneously To Deliver Stimulation, |