Data / Medical devices / United States / Electro-Cap Intl., Inc.
Electro-Cap Intl., Inc.: FDA-registered device maker in Eaton, OH, United States, 3 510(k) clearances
Electro-Cap Intl., Inc. is registered with the FDA (registration 1626185) in Eaton, OH, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 27, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1626185
- FEI number
- 1000119368
- Address
- 1011 W Lexington Rd, Eaton, OH, United States, 45320
- Owner or operator
- ELECTRO-CAP INTL., INC. (1626185)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- October 11, 2007
- Registered through
- 2026
- Brand names listed
- Electro-Cap, Electro-Cap System, Electro-Gel
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrode, Cutaneous | GXY | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Media, Electroconductive | GYB | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| January 27, 2012 | K112319 | ELECTRO-CAP SYSTEM | GXY | Substantially Equivalent | Electro-Cap Intl., Inc. | accessdata.fda.gov |
| January 5, 2012 | K111717 | ELECTRO-GEL | GYB | Substantially Equivalent | Electro-Cap Intl., Inc. | accessdata.fda.gov |
| January 24, 1978 | K780045 | ELECTRODE CAP | GXY | Substantially Equivalent | Electro-Cap Intl., Inc. | accessdata.fda.gov |
Compare with other makers
Updated January 27, 2012. 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.