K173861 is an FDA 510(k) clearance for the Drug Relief. This device is classified as a Percutaneous Nerve Stimulator For Opioid Withdrawal (Class II - Special Controls, product code PZR).
Submitted by Dyansys, Inc. (San Mateo, US). The FDA issued a Cleared decision on May 2, 2018, 133 days after receiving the submission on December 20, 2017.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5896. Stimulate Nerve Branches To Aid In The Reduction Of Symptoms Associated With Substance Use Disorders..
| 510(k) Number | K173861 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 2017 |
| Decision Date | May 02, 2018 |
| Days to Decision | 133 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | PZR - Percutaneous Nerve Stimulator For Opioid Withdrawal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5896 |
| Definition | Stimulate Nerve Branches To Aid In The Reduction Of Symptoms Associated With Substance Use Disorders. |