Electro-Med Health Industries, Inc.: FDA clearances and approvals
Electro-Med Health Industries, Inc. has 6 FDA 510(k) clearances (first 1980, latest 1985), across 4 product codes in 1 review panel. Median 510(k) review time: 46 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 |
|---|---|---|---|
| IPF | Stimulator, Muscle, Powered | 2 | 2 |
| IMA | Pack, Heat, Moist | 1 | 1 |
| INQ | Table, Powered | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Electro-Med Health Industries, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K852077 | VERSA STIM 380, MUSCLE STIMULATOR | IPF | 1985-08-21 | 100 |
| K832371 | EGS MODEL 300 | — | 1983-10-06 | 80 |
| K832804 | SESAM TABLE | INQ | 1983-09-20 | 33 |
| K832803 | STEAM PAK MOIST HEAT | IMA | 1983-09-20 | 33 |
| K832370 | EGS MODEL 100-2 | — | 1983-09-16 | 60 |
| K802107 | EGS #300 BATTERY OPER. PORTA. MUSCLE STI | IPF | 1980-10-03 | 30 |
Recalls
openFDA lists no recalls under a recalling firm named Electro-Med Health Industries, 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 Electro-Med Health Industries, Inc. have?
Electro-Med Health Industries, Inc. has 6 FDA 510(k) clearances (first 1980, latest 1985), across 4 product codes in 1 review panel.
How long does FDA take to clear Electro-Med Health Industries, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Electro-Med Health Industries, Inc.'s cleared 510(k)s is 46 days.
What devices does Electro-Med Health Industries, Inc. make?
Its most frequent FDA product codes are IPF (Stimulator, Muscle, Powered, 2); IMA (Pack, Heat, Moist, 1); INQ (Table, Powered, 1).
Has Electro-Med Health Industries, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Electro-Med Health Industries, Inc. Related entities may recall under other names.
Next steps
- See all 6 Electro-Med Health Industries, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IPF, Electro-Med Health Industries, 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.