PZR
8 FDA 510(k) clearances · Product code
134 daysmedian time to decision
245 days90th percentile
8clearances measured
FDA profile
- Official device name
- Percutaneous Nerve Stimulator For Opioid Withdrawal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.5896
- Medical specialty
- Neurology
- FDA definition
- Stimulate nerve branches to aid in the reduction of symptoms associated with substance use disorders.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Sparrow Ascent (K251246) | Spark Biomedical, Inc. | 2025-08-25 |
| NET Recovery Corp/NET Device (K233166) | Net Recovery | 2024-05-29 |
| Sparrow Ascent (K230796) | Spark Biomedical, Inc. | 2023-06-20 |
| Drug Relief v1 (K221231) | Dyansys, Inc. | 2022-06-06 |
| Drug Relief v1 (K211971) | Dyansys, Inc. | 2021-11-05 |
| Sparrow Therapy System (K201873) | Spark Biomedical, Inc. | 2021-01-02 |
| Drug Relief (K173861) | Dyansys, Inc. | 2018-05-02 |
| NSS-2 System (DEN170018) | Innovative Health Solutions (Ihs), Inc. | 2017-11-15 |
Track PZR automatically
Every clearance here is in the API, with alerts when new ones post.