510(k) Report

FDA applicant

National Health-Care Equipment, Inc.

Mount Vernon, NY4 decisions1991–19920 recalls

FDA records 4 decisions for National Health-Care Equipment, Inc. (Mount Vernon, NY) from 1991 to 1992: 4 510(k) clearances. Most are in product codes ILY (Lamp, Infrared, Therapeutic Heating) and ELY (Mercury). 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 National Health-Care Equipment, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for National Health-Care Equipment, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like National Health-Care Equipment, 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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Which product codes does it file in?

  • ILYLamp, Infrared, Therapeutic Heating3decisions
  • ELYMercury1decision

What has FDA decided for it lately?

  • K913814Model #05 Aneroid Sphygmomanometer KitNational Health-Care Equipment, Inc. · 1992
  • K913880Infrared Heat Lamp Model NH-202National Health-Care Equipment, Inc. · 1991
  • K913973Infrared Heat Lamps & Massager Model NH-213National Health-Care Equipment, Inc. · 1991
  • K913856Infrared Heat Lamp Model NH-201National Health-Care Equipment, Inc. · 1991

All 4 as National Health-Care Equipment, Inc. →