FDA product code · Neurology · Class 2
NUH: Stimulator, Nerve, Transcutaneous, Over-The-Counter
NUH is FDA's product code for "Stimulator, Nerve, Transcutaneous, Over-The-Counter": a Class 2 device classified under 21 CFR 882.5890, reviewed by the Neurology panel.
510(k) review time for NUH
Across 137 510(k) clearances under NUH decided from 2018-01-01 to 2026-10-06, the median was 138 days from FDA receipt to decision. Half took between 90 and 248 days, and 80% were decided within 265 days. These are past clearances, not a forecast for a new submission.
| Fastest | 28 |
|---|---|
| 25th percentile | 90 |
| Median | 138 |
| 75th percentile | 248 |
| 80th percentile | 265 |
| 90th percentile | 341 |
| Slowest | 580 |
| Year | Median days | n |
|---|---|---|
| 2018 | 121 | 16 |
| 2019 | 213 | 19 |
| 2020 | 147 | 14 |
| 2021 | 198 | 14 |
| 2022 | 103 | 20 |
| 2023 | 127 | 15 |
| 2024 | 90 | 20 |
| 2025 | 119 | 15 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
NUH in the public FDA record
| 510(k) clearances, all years | 230 |
|---|---|
| Establishment listings | 462 |
| GUDID device identifiers | 1,128 |
Counts of records, not of devices or events. Adverse event reports for NUH are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite NUH
1 FDA recognized consensus standard cite NUH, among them IEC 60601-2-10 Edition 2.2 2023-01 CONSOLIDATED VERSION. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 17-22 IEC 60601-2-10 Edition 2.2 2023-01 CONSOLIDATED VERSION — Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.