GZIClass II
Stimulator, Neuromuscular, External Functional
21 CFR 882.5810 / Neurology
GZI is the FDA product code for Stimulator, Neuromuscular, External Functional, a class II device type, regulated under 21 CFR 882.5810. As of , FDA records hold 61 510(k) clearances under this code, the most recent dated , and 2 recalls.
Classification record
- Product code
- GZI
- Device name
- Stimulator, Neuromuscular, External Functional
- Regulation
- 21 CFR 882.5810
- Device class
- Class II
- Review panel
- Neurology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 61
- Ingested recalls
- 2
Clearances, product code GZI
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 2 |
| 1980 | 1 |
| 1982 | 1 |
| 1987 | 1 |
| 1991 | 2 |
| 1992 | 1 |
| 1995 | 1 |
| 1998 | 1 |
| 2001 | 2 |
| 2003 | 1 |
| 2005 | 3 |
| 2006 | 2 |
| 2007 | 4 |
| 2008 | 1 |
| 2009 | 1 |
| 2011 | 6 |
| 2012 | 2 |
| 2013 | 2 |
| 2014 | 3 |
| 2015 | 1 |
| 2016 | 1 |
| 2017 | 6 |
| 2018 | 2 |
| 2019 | 2 |
| 2020 | 2 |
| 2021 | 1 |
| 2022 | 4 |
| 2023 | 1 |
| 2024 | 2 |
| 2025 | 2 |
Applicants with the most clearances
Product code GZI| Applicant | Clearances |
|---|---|
| Bioness, Inc. | 9 |
| Restorative Therapies Inc. | 9 |
| Ness-Neuromuscular Electrical Stimulation Systems | 5 |
| Hasomed GmbH | 4 |
| Cionic | 3 |
| Innovative Neurotronics, Inc. | 3 |
| Myndtec Inc | 3 |
| Myolyn Inc. | 2 |
| Odstock Medical Ltd | 2 |
| Shenzhen XFT Medical Limited | 2 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.