Electromedical Products, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Electromedical Products, Inc.” (first 1983, latest 1992), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 90 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 |
|---|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 4 | 4 |
| QJQ | Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety | 1 | 1 |
Review panels
- Neurology (5)
Most recent Electromedical Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K903014 | ALPHA-STIM CS | QJQ | 1992-05-12 | 672 |
| K896948 | ALPHA-STIM CS | GZJ | 1990-02-23 | 72 |
| K881753 | ALPHA-STIM 350 | GZJ | 1988-08-30 | 131 |
| K831145 | ALPHA-STIM 350 | GZJ | 1983-07-07 | 90 |
| K831144 | ALPHA-STIM 2000 | GZJ | 1983-06-30 | 83 |
Recalls
openFDA lists no recalls under a recalling firm named Electromedical Products, 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 Electromedical Products, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Electromedical Products, Inc.” (first 1983, latest 1992), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Electromedical Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Electromedical Products, Inc. is 90 days.
Which FDA product codes appear under Electromedical Products, Inc.?
The most frequent FDA product codes under this applicant name are GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 4); QJQ (Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety, 1).
Next steps
- See all 5 Electromedical Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GZJ, Electromedical Products, 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.