FDA product code · Neurology · Class 2
GZJ: Stimulator, Nerve, Transcutaneous, For Pain Relief
GZJ is FDA's product code for "Stimulator, Nerve, Transcutaneous, For Pain Relief": a Class 2 device classified under 21 CFR 882.5890, reviewed by the Neurology panel.
510(k) review time for GZJ
Across 23 510(k) clearances under GZJ decided from 2018-01-01 to 2026-10-06, the median was 161 days from FDA receipt to decision. Half took between 121 and 255 days, and 80% were decided within 263 days. These are past clearances, not a forecast for a new submission.
| Fastest | 29 |
|---|---|
| 25th percentile | 121 |
| Median | 161 |
| 75th percentile | 255 |
| 80th percentile | 263 |
| 90th percentile | 360 |
| Slowest | 783 |
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.
GZJ in the public FDA record
| 510(k) clearances, all years | 606 |
|---|---|
| Establishment listings | 372 |
| GUDID device identifiers | 1,328 |
Counts of records, not of devices or events. Adverse event reports for GZJ 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 GZJ
2 FDA recognized consensus standards cite GZJ, among them ANSI AAMI NS4:2013(R)2017; 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.
- 17-14 ANSI AAMI NS4:2013(R)2017 — Transcutaneous Electrical Nerve Stimulators
- 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.