FDA product code · Neurology · Class 2
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
NFO is FDA's product code for "Stimulator, Transcutaneous Electrical, Aesthetic Purposes": a Class 2 device classified under 21 CFR 882.5890, reviewed by the Neurology panel.
510(k) review time for NFO
Across 55 510(k) clearances under NFO decided from 2018-01-01 to 2026-10-06, the median was 139 days from FDA receipt to decision. Half took between 88 and 218 days, and 80% were decided within 240 days. These are past clearances, not a forecast for a new submission.
| Fastest | 3 |
|---|---|
| 25th percentile | 88 |
| Median | 139 |
| 75th percentile | 218 |
| 80th percentile | 240 |
| 90th percentile | 279 |
| Slowest | 645 |
| Year | Median days | n |
|---|---|---|
| 2018 | 177 | 5 |
| 2021 | 210 | 7 |
| 2023 | 128 | 8 |
| 2024 | 109 | 5 |
| 2025 | 124 | 16 |
| 2026 (to 10-06, partial) | 142 | 7 |
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.
NFO in the public FDA record
| 510(k) clearances, all years | 80 |
|---|---|
| Establishment listings | 106 |
Counts of records, not of devices or events. Adverse event reports for NFO 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 NFO
No FDA recognized consensus standard cites NFO by product code. Horizontal standards such as biocompatibility, sterilization and software standards can still apply.
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.