Ness-Neuromuscular Electrical Stimulation Systems: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Ness-Neuromuscular Electrical Stimulation Systems” (first 2001, latest 2011), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 50 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GZI | Stimulator, Neuromuscular, External Functional | 5 | 5 |
| IPF | Stimulator, Muscle, Powered | 1 | 1 |
| IPG | Shoe, Cast | 1 | 1 |
Review panels
- Neurology (5)
- Physical Medicine (2)
Most recent Ness-Neuromuscular Electrical Stimulation Systems 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K111767 | NESS H200 WIRELESS HAND REHABILITATION SYSTEM USER KIT AND CLINICAN KIT | GZI | 2011-09-15 | 84 |
| K080219 | MODIFICATION TO:NESS L300 | GZI | 2008-02-28 | 30 |
| K053468 | NESS L300 | GZI | 2006-07-07 | 206 |
| K031900 | HANDMASTER | GZI | 2003-08-08 | 50 |
| K024279 | NESS CHILDREN SYSTEM | IPG | 2003-02-05 | 44 |
| K022776 | NESS SYSTEM | IPF | 2002-09-11 | 21 |
| K012823 | MODIFICATION TO HANDMASTER | GZI | 2001-11-14 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Ness-Neuromuscular Electrical Stimulation Systems.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Ness-Neuromuscular Electrical Stimulation Systems?
FDA lists 7 510(k) clearances under the applicant name “Ness-Neuromuscular Electrical Stimulation Systems” (first 2001, latest 2011), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ness-Neuromuscular Electrical Stimulation Systems?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ness-Neuromuscular Electrical Stimulation Systems is 50 days.
Which FDA product codes appear under Ness-Neuromuscular Electrical Stimulation Systems?
The most frequent FDA product codes under this applicant name are GZI (Stimulator, Neuromuscular, External Functional, 5); IPF (Stimulator, Muscle, Powered, 1); IPG (Shoe, Cast, 1).
Next steps
- See all 7 Ness-Neuromuscular Electrical Stimulation Systems clearances with predicates and recalls
- Run predicate analysis for product code GZI, Ness-Neuromuscular Electrical Stimulation Systems's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.