FDA applicant

Electro-Cap Intl., Inc.

Eaton, OH3 decisions1978–20120 recalls

FDA records 3 decisions for Electro-Cap Intl., Inc. (Eaton, OH) from 1978 to 2012: 3 510(k) clearances. Most are in product codes GXY (Electrode, Cutaneous) and GYB (Media, Electroconductive). Its devices cite 8 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Electro-Cap Intl., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2012

2007high 2 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Electro-Cap Intl., Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Electro-Cap Intl., Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Electro-Cap”

FDA records each applicant name separately; these may or may not be the same firm.

Electro-Nucleonics Laboratories, Inc. 41 Electro-Catheter Corp. 35 Electro-Biology, Inc. 28 Electro Medical Systems SA 11 Electro-Nucleonics, Inc. 9 Electro Therapeutic Devices, Inc. 8 Electro Med Supply, Inc. 8 Electro-Med Health Industries, Inc. 6 Electro-Diagnostic Instruments 4 Electro Medical Systems (Ems Sa) 3 Electro Fiberoptics Corp. 3 Electro-Diagnostic Imaging, Inc. 2

Electro-Cap Intl., Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Electro-Cap”