Electro Med Supply, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Electro Med Supply, Inc.” (first 1986, latest 1994), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 118 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 |
|---|---|---|---|
| IPF | Stimulator, Muscle, Powered | 7 | 7 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 1 | 1 |
Review panels
- Physical Medicine (7)
- Neurology (1)
Most recent Electro Med Supply, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K933368 | TENS-IT | GZJ | 1994-06-07 | 333 |
| K872208 | MS-112, POWERED MUSCLE STIMULATOR | IPF | 1987-10-06 | 120 |
| K872207 | MS-108, POWERED MUSCLE STIMULATOR | IPF | 1987-10-06 | 120 |
| K872206 | MD-104, POWERED MUSCLE STIMULATOR | IPF | 1987-10-06 | 120 |
| K862487 | MS-139 ELECTRONIC MUSCLE STIMULATOR | IPF | 1986-07-16 | 16 |
| K862486 | MS-159 ELECTRONIC MUSCLE STIMULATOR | IPF | 1986-07-16 | 16 |
| K862485 | MS-179 ELECTRONIC MUSCLE STIMULATOR | IPF | 1986-07-16 | 16 |
| K854801 | MS-189 MUSCLE STIMULATOR | IPF | 1986-03-27 | 115 |
Recalls
openFDA lists no recalls under a recalling firm named Electro Med Supply, 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Electro Medical Systems SA (9 510(k)s)
- Electro Therapeutic Devices, Inc. (8 510(k)s)
- Electro Fiberoptics Corp. (3 510(k)s)
- Electro Medical Systems (Ems Sa) (2 510(k)s)
- Electro Medica Office (2 510(k)s)
- Electro Medical Systems, Inc. (2 510(k)s)
- Electro Science Technologies, Inc. (2 510(k)s)
- Electro Kinetic Technologies, LLC (1 510(k)s)
- Electro Medical Development (1 510(k)s)
- Electro Medical Equipment Co., Inc. (1 510(k)s)
- Electro Optical Instruments (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Electro Med Supply, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Electro Med Supply, Inc.” (first 1986, latest 1994), across 2 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 Electro Med Supply, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Electro Med Supply, Inc. is 118 days.
Which FDA product codes appear under Electro Med Supply, Inc.?
The most frequent FDA product codes under this applicant name are IPF (Stimulator, Muscle, Powered, 7); GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 1).
Next steps
- See all 8 Electro Med Supply, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IPF, Electro Med Supply, 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.