Med-Western Electronics, Inc.: FDA clearances and approvals
Med-Western Electronics, Inc. has 5 FDA 510(k) clearances (first 1980, latest 1981), across 3 product codes in 3 review panels. Median 510(k) review time: 41 days.
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 company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Med-Western Electronics, Inc. have?
Med-Western Electronics, Inc. has 5 FDA 510(k) clearances (first 1980, latest 1981), across 3 product codes in 3 review panels.
How long does FDA take to clear Med-Western Electronics, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Med-Western Electronics, Inc.'s cleared 510(k)s is 41 days.
What devices does Med-Western Electronics, Inc. make?
Its most frequent FDA product codes are IXC (Illuminator, Radiographic-Film, 3); GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 1); IPF (Stimulator, Muscle, Powered, 1).
Has Med-Western Electronics, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Med-Western Electronics, Inc. Related entities may recall under other names.
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. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.