FDA product code NHI: Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief
NHI is the FDA product code for stimulator, nerve, electrical, percutaneous (pens), for pain relief. It is a Class II device, regulated under 21 CFR 882.5890 and reviewed by the Neurology panel. FDA has cleared 13 510(k) submissions under NHI, 4 in the last five years, from 5 different applicants. The average 510(k) review took 107 days (median 103).
Definition
Percutaneous electrical nerve stimulator (pens) is a device used for the treatment of pain. Unlike the classified transcutaneous electrical nerve stimulator that apply an electrical current to electrodes on a patient's skin to deliver stimulation, a pens uses electrodes that are placed percutaneously to deliver stimulation,
Classification
| Field | Value |
|---|---|
| Device name | Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief |
| Device class | Class II |
| Regulation | 21 CFR 882.5890 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for NHI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 90 |
| 2018 | 1 | 61 |
| 2021 | 3 | 119 |
| 2022 | 3 | 111 |
| 2023 | 1 | 90 |
Compare with all 510(k) review times · Search every NHI clearance
Top NHI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Spr Therapeutics, Inc. | 4 | 2023-01-25 |
| Dyansys, Inc. | 4 | 2022-09-13 |
| Spr Therapeutics, LLC | 2 | 2017-06-26 |
| Vertis Neuroscience, Inc. | 2 | 2002-09-11 |
| Biowave Corporation | 1 | 2006-08-15 |
Most recent NHI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K223306 | Spr Therapeutics, Inc. | SPRINT Peripheral Nerve Stimulation (PNS) System | 2023-01-25 | 90 |
| K221425 | Dyansys, Inc. | Primary Relief | 2022-09-13 | 120 |
| K220397 | Dyansys, Inc. | ANSiStim-PP | 2022-05-12 | 90 |
| K213188 | Dyansys, Inc. | Primary Relief | 2022-01-31 | 124 |
| K212859 | Dyansys, Inc. | First Relief | 2021-12-20 | 103 |
Recalls for NHI devices
openFDA lists no recalls for product code NHI.
Frequently asked questions
What is FDA product code NHI?
NHI is the FDA product code for stimulator, nerve, electrical, percutaneous (pens), for pain relief. It is a Class II device, regulated under 21 CFR 882.5890 and reviewed by the Neurology panel.
What device class is NHI?
Class II, regulation 21 CFR 882.5890. Typical premarket route: 510(k).
How long does a 510(k) take for product code NHI?
Across 13 cleared submissions the average was 107 days from receipt to decision (median 103).
Which companies have the most NHI clearances?
Spr Therapeutics, Inc. (4); Dyansys, Inc. (4); Spr Therapeutics, LLC (2); Vertis Neuroscience, Inc. (2); Biowave Corporation (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NHI
- Run a recall and safety report across every NHI manufacturer
- Watch product code NHI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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