FDA product code GZI: Stimulator, Neuromuscular, External Functional
GZI is the FDA product code for stimulator, neuromuscular, external functional. It is a Class II device, regulated under 21 CFR 882.5810 and reviewed by the Neurology panel. FDA has cleared 61 510(k) submissions under GZI, 9 in the last five years, from 30 different applicants. The average 510(k) review took 153 days (median 123); 236 days on average over the last three years. FDA has posted 2 recalls for GZI devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Stimulator, Neuromuscular, External Functional |
| Device class | Class II |
| Regulation | 21 CFR 882.5810 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for GZI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 6 | 216 |
| 2018 | 2 | 182 |
| 2019 | 2 | 60 |
| 2020 | 2 | 166 |
| 2021 | 1 | 463 |
| 2022 | 4 | 121 |
| 2023 | 1 | 265 |
| 2024 | 2 | 269 |
| 2025 | 2 | 204 |
Compare with all 510(k) review times · Search every GZI clearance
Top GZI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bioness, Inc. | 9 | 2020-03-04 |
| Restorative Therapies, Inc. | 9 | 2017-07-11 |
| Ness-Neuromuscular Electrical Stimulation Systems | 5 | 2011-09-15 |
| Hasomed GmbH | 4 | 2017-02-03 |
| Myndtec, Inc. | 3 | 2024-06-25 |
25 more applicants have GZI clearances. See the full list in Caduvo.
Most recent GZI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K242704 | Synapse Biomedical, Inc. | Synchrony (20-3000) | 2025-06-05 | 269 |
| K243828 | Cionic, Inc. | CIONIC NEURAL SLEEVE (NS-200) | 2025-05-02 | 140 |
| K240632 | Neuvotion, Inc. | Neuvotion NeuStim NN-01 | 2024-11-22 | 261 |
| K233006 | Myndtec, Inc. | MyndMove, MyndMove 2.0 | 2024-06-25 | 277 |
| K230997 | Evolution Devices, Inc. | EvoWalk 1.0 System | 2023-12-28 | 265 |
Recalls for GZI devices
2 product recalls in 2 recall events; 1 initiated in the last five years and 0 still open. Most recent: 2022-07-19.
| Year | Recalls |
|---|---|
| 2022 | 1 |
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- L8678 — Electrical stimulator supplies (external) for use with implantable neurostimulator, per month
Frequently asked questions
What is FDA product code GZI?
GZI is the FDA product code for stimulator, neuromuscular, external functional. It is a Class II device, regulated under 21 CFR 882.5810 and reviewed by the Neurology panel.
What device class is GZI?
Class II, regulation 21 CFR 882.5810. Typical premarket route: 510(k).
How long does a 510(k) take for product code GZI?
Across 61 cleared submissions the average was 153 days from receipt to decision (median 123).
Which companies have the most GZI clearances?
Bioness, Inc. (9); Restorative Therapies, Inc. (9); Ness-Neuromuscular Electrical Stimulation Systems (5); Hasomed GmbH (4); Myndtec, Inc. (3).
Have GZI devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2022-07-19.
Next steps
- Run an FDA pathway report with predicate devices for product code GZI
- Run a recall and safety report across every GZI manufacturer
- Watch product code GZI 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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