K212859 is an FDA 510(k) clearance for the First 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 December 20, 2021, 103 days after receiving the submission on September 8, 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 | K212859 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 08, 2021 |
| Decision Date | December 20, 2021 |
| Days to Decision | 103 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, |