FDA applicant

Rochester Electro Medical, Inc.

Lutz, FL2 decisions2008–20150 recalls

FDA records 2 decisions for Rochester Electro Medical, Inc. (Lutz, FL) from 2008 to 2015: 2 510(k) clearances. Most are in product codes IKT (Electrode, Needle, Diagnostic Electromyograph) and GXY (Electrode, Cutaneous). Its devices cite 8 predicates, 0 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, physical medicine panel, where it files most

How often FDA has decided Rochester Electro Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Rochester Electro Medical, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Rochester Electro Medical, 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 “Rochester”

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

Rochester Medical Corp. 14

Rochester Electro Medical, 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 “Rochester”