Data / Medical devices / Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief
Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief (NHI): 8 FDA-registered makers in 3 countries
8 establishments in 3 countries are registered with the FDA to make Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief (product code NHI, Class 2, 21 CFR 882.5890). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 13 510(k) clearances under this code, the latest on January 25, 2023, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- NHI
- Device class
- 2
- Regulation
- 882.5890
- Medical specialty
- Neurology
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| India | 1 |
| Costa Rica | 1 |
Makers of Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief
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 | 4 | September 13, 2022 | 0 | 0 | 0 | api.fda.gov |
| Biowave Corporation | Norwalk, CT, United States | Manufacturer, Specification developer | 1 | August 15, 2006 | 0 | 0 | 0 | api.fda.gov |
| SPR Therapeutics, Inc | Cleveland, OH, United States | Manufacturer | 1 | January 25, 2023 | 0 | 0 | 0 | api.fda.gov |
| Cardinal Health | Wabasha, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jomel Seams Reasonable LLC | Hillside, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Katecho LLC | Des Moines, IA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nextern Costa Rica Ltd. | Cartago, Costa Rica | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Viant San Antonio, Inc. | San Antonio, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 25, 2023. 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.