K233166 is an FDA 510(k) clearance for the NET Recovery Corp/NET Device. This device is classified as a Percutaneous Nerve Stimulator For Opioid Withdrawal (Class II - Special Controls, product code PZR).
Submitted by Net Recovery (Anaheim Hills, US). The FDA issued a Cleared decision on May 29, 2024, 245 days after receiving the submission on September 27, 2023.
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 | K233166 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 2023 |
| Decision Date | May 29, 2024 |
| Days to Decision | 245 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. |