Med-Western Electronics, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Med-Western Electronics, Inc.” (first 1980, latest 1981), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 41 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 |
|---|---|---|---|
| IXC | Illuminator, Radiographic-Film | 3 | 3 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 1 | 1 |
| IPF | Stimulator, Muscle, Powered | 1 | 1 |
Review panels
- Radiology (3)
- Neurology (1)
- Physical Medicine (1)
Most recent Med-Western Electronics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K813100 | BIO-STIMULATOR, MODEL 400 | GZJ | 1981-11-27 | 24 |
| K810225 | LITRONIC STIMULATOR | IPF | 1981-03-30 | 62 |
| K802217 | VIEW-LITE, MODEL-SL | IXC | 1980-10-23 | 41 |
| K802216 | VIEW-LITE, MODEL-DL | IXC | 1980-10-23 | 41 |
| K802215 | VIEW-LITE, MODEL-S | IXC | 1980-10-23 | 41 |
Recalls
openFDA lists no recalls under a recalling firm named Med-Western Electronics, Inc..
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 Med-Western Electronics, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Med-Western Electronics, Inc.” (first 1980, latest 1981), across 3 product codes in 3 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 Med-Western Electronics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Med-Western Electronics, Inc. is 41 days.
Which FDA product codes appear under Med-Western Electronics, Inc.?
The most frequent FDA product codes under this applicant name are IXC (Illuminator, Radiographic-Film, 3); GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 1); IPF (Stimulator, Muscle, Powered, 1).
Next steps
- See all 5 Med-Western Electronics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IXC, Med-Western Electronics, Inc.'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.