Data / Medical devices / Percutaneous Nerve Stimulator For Opioid Withdrawal
Percutaneous Nerve Stimulator For Opioid Withdrawal (PZR): 6 FDA-registered makers in 3 countries
6 establishments in 3 countries are registered with the FDA to make Percutaneous Nerve Stimulator For Opioid Withdrawal (product code PZR, Class 2, 21 CFR 882.5896). 3 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 8 510(k) clearances under this code, the latest on August 25, 2025, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PZR
- Device class
- 2
- Regulation
- 882.5896
- Medical specialty
- Neurology
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| India | 1 |
| Mexico | 1 |
Makers of Percutaneous Nerve Stimulator For Opioid Withdrawal
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Neurostimulation Medtech Private Limited | Chennai Tamil Nadu, India | Manufacturer | 2 | June 6, 2022 | 0 | 0 | 0 | api.fda.gov |
| Spark Biomedical Inc. | Richmond, TX, United States | Complaint file establishment, Manufacturer, Specification developer | 2 | August 25, 2025 | 0 | 1 | 0 | api.fda.gov |
| Net Recovery Corp | Costa Mesa, CA, United States | Manufacturer | 1 | May 29, 2024 | 0 | 0 | 0 | api.fda.gov |
| Gmi Corporation | Franklin, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hi-Tech Products De Mexico S.A. De C.V. | La Mesa, Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Velentium Medical | Richmond, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 25, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.