FDA applicant
Uni-Patch, Inc.
FDA records 6 decisions for Uni-Patch, Inc. (Wabasha, MN) from 1987 to 1999: 6 510(k) clearances. Most are in product codes GXY (Electrode, Cutaneous) and GZJ (Stimulator, Nerve, Transcutaneous, For Pain…). Its devices cite 3 predicates, 1 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
How often FDA has decided Uni-Patch, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Uni-Patch, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Uni-Patch, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report