K211971 is an FDA 510(k) clearance for the Drug Relief v1. 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 November 5, 2021, 134 days after receiving the submission on June 24, 2021.
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 | K211971 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 24, 2021 |
| Decision Date | November 05, 2021 |
| Days to Decision | 134 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. |