Data / Medical devices / United States / Electromedical Products Intl., Inc.
Electromedical Products Intl., Inc.: FDA-registered device maker in Mineral Wells, TX, United States, 2 510(k) clearances
Electromedical Products Intl., Inc. is registered with the FDA (registration 2020648) in Mineral Wells, TX, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 12, 1992. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2020648
- Address
- 2201 Garrett Morris Pkwy., Mineral Wells, TX, United States, 76067
- Owner or operator
- ELECTROMEDICAL PRODUCTS INTL., INC. (9027065)
- Roles
- Manufacturer, Specification developer
- First device listed
- November 29, 2007
- Registered through
- 2026
- Brand names listed
- 100,, Alpha-Stim AID, M, SCS, Trudenta Alpha-Stim M, Alpha-Stim M, Trudenta Alpha-Stim M,Alpha-Stim 100, Alpha-Stim SCS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety | QJQ | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 12, 1992 | K903014 | ALPHA-STIM CS | QJQ | Substantially Equivalent | Electromedical Products, Inc. | accessdata.fda.gov |
| February 23, 1990 | K896948 | ALPHA-STIM CS | GZJ | Substantially Equivalent | Electromedical Products, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
- All makers of Stimulator, Nerve, Transcutaneous, For Pain Relief
Updated May 12, 1992. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.