Percutaneous Nerve Stimulator For Opioid Withdrawal
The Percutaneous Nerve Stimulator for Opioid Withdrawal is a device that stimulates peripheral nerve branches percutaneously to aid in the reduction of symptoms associated with opioid and other substance use disorders during withdrawal. It is classified as a Class 2 device under regulation 882.5896, requiring 510(k) premarket notification, and falls within the Neurology (NE) medical specialty. The product code is PZR. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PZR
- Device Class
- FDA class 2
- Regulation Number
- 882.5896
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
Definition
Stimulate nerve branches to aid in the reduction of symptoms associated with substance use disorders.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K251246 | Sparrow Ascent | Aug 25, 2025 | Substantially Equivalent | Spark Biomedical, Inc. |
| K233166 | NET Recovery Corp/NET Device | May 29, 2024 | Substantially Equivalent | Net Recovery |
| K230796 | Sparrow Ascent | Jun 20, 2023 | Substantially Equivalent | Spark Biomedical, Inc. |
| K221231 | Drug Relief v1 | Jun 06, 2022 | Substantially Equivalent | Dyansys, Inc. |
| K211971 | Drug Relief v1 | Nov 05, 2021 | Substantially Equivalent | Dyansys, Inc. |
| K201873 | Sparrow Therapy System | Jan 02, 2021 | Substantially Equivalent | Spark Biomedical, Inc. |
| K173861 | Drug Relief | May 02, 2018 | Substantially Equivalent | Dyansys, Inc. |
| DEN170018 | NSS-2 System | Nov 15, 2017 | Unknown | Innovative Health Solutions (Ihs), Inc. |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.