NET Recovery Corp/NET Device
FDA 510(k) K233166 · Net Recovery
510(k) numberK233166
Submission
- Device name
- NET Recovery Corp/NET Device
- Applicant
- Net Recovery
Anaheim Hills, CA, US - Received
- September 27, 2023
- Decision date
- May 29, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code PZR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251246 | Sparrow AscentPZR · Traditional | Spark Biomedical, Inc. | 08/25/2025SE |
| K230796 | Sparrow AscentPZR · Traditional | Spark Biomedical, Inc. | 06/20/2023SE |
| K221231 | Drug Relief v1PZR · Special | Dyansys, Inc. | 06/06/2022SE |
| K211971 | Drug Relief v1PZR · Traditional | Dyansys, Inc. | 11/05/2021SE |
| K201873 | Sparrow Therapy SystemPZR · Traditional | Spark Biomedical, Inc. | 01/02/2021SE |
| K173861 | Drug ReliefPZR · Traditional | Dyansys, Inc. | 05/02/2018SE |
Questions and answers
When was NET Recovery Corp/NET Device cleared by the FDA?
NET Recovery Corp/NET Device (K233166) received a 510(k) decision of Substantially Equivalent on May 29, 2024, 245 days after the submission was received.
What is the product code of K233166?
The FDA product code is PZR – Percutaneous Nerve Stimulator For Opioid Withdrawal, a Class II (moderate risk) device regulated under 21 CFR 882.5896.