510(k) Report

FDA applicant

Class A Ent.

Yucca Valley, CA3 decisions1992–20020 recalls

FDA records 3 decisions for Class A Ent. (Yucca Valley, CA) from 1992 to 2002: 3 510(k) clearances. Most are in product codes GXZ (Electrode, Needle) and GXY (Electrode, Cutaneous). 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 Class A Ent.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Class A Ent. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Class A Ent.’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

Other applicant names beginning “Class”

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