FDA product code · Neurology · Class 2
GZI: Stimulator, Neuromuscular, External Functional
GZI is FDA's product code for "Stimulator, Neuromuscular, External Functional": a Class 2 device classified under 21 CFR 882.5810, reviewed by the Neurology panel.
510(k) review time for GZI
Across 16 510(k) clearances under GZI decided from 2018-01-01 to 2026-10-06, the median was 189 days from FDA receipt to decision. Half took between 90 and 266 days, and 80% were decided within 269 days. These are past clearances, not a forecast for a new submission.
| Fastest | 28 |
|---|---|
| 25th percentile | 90 |
| Median | 189 |
| 75th percentile | 266 |
| 80th percentile | 269 |
| 90th percentile | 290 |
| Slowest | 463 |
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.
GZI in the public FDA record
| 510(k) clearances, all years | 61 |
|---|
Counts of records, not of devices or events. Adverse event reports for GZI 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 GZI
No FDA recognized consensus standard cites GZI 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.