510(k) Report

FDA applicant

Cosmo Health, Inc.

West Caldwell, NJ1 decision2002–20020 recalls

FDA records 1 decision for Cosmo Health, Inc. (West Caldwell, NJ) in 2002: 1 510(k) clearance. All are in product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain…). 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 Cosmo Health, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cosmo Health, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Cosmo Health, 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 “Cosmo”

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