510(k) Report

FDA applicant

Royal Enterprises Manufacturing, Inc.

Madison, WI2 decisions1987–19880 recalls

FDA records 2 decisions for Royal Enterprises Manufacturing, Inc. (Madison, WI) from 1987 to 1988: 2 510(k) clearances. All are in product code INI (Vehicle, Motorized 3-Wheeled). 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 Royal Enterprises Manufacturing, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Royal Enterprises Manufacturing, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • INIVehicle, Motorized 3-Wheeled2decisions

What has FDA decided for it lately?

  • K881766Rem 250 Three Wheeled Electric CartRoyal Enterprises Manufacturing, Inc. · 1988
  • K872518REM500 Three Wheeled Elec. Cart.Royal Enterprises Manufacturing, Inc. · 1987

All 2 as Royal Enterprises Manufacturing, Inc. →

Other applicant names beginning “Royal”

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

Royal American Industries, Inc. 2Royal Oak Medical Devices 2Royal Precision Plastics, Inc. 1Royal King Infant Products Co., Ltd. 1Royal Flash Enterprise Co., Ltd. 1Royal Industries (Thailand) Public Co., Ltd. 1Royal Shine Enterprises, Ltd. 1Royal Scientific, Inc. 1Royal Dental Lab 1Royal Plastic Sarl 1Royal Pacific Intl. Trade, Inc. 1