Submission Details
| 510(k) Number | K233166 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
NET Recovery Corp/NET Device
May 2024
Decision
245d
Days
Class 2
Risk
About This 510(k) Submission
K233166 is an FDA 510(k) clearance for the NET Recovery Corp/NET Device, 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 review panel. Regulated under 21 CFR 882.5896.
Device Classification
| 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. |
Manufacturer
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