510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K881766Substantially Equivalent

Rem 250 Three Wheeled Electric Cart

Royal Enterprises Manufacturing, Inc., Madison WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K881766 is the FDA 510(k) clearance record for REM 250 THREE WHEELED ELECTRIC CART, a class II device, cleared for Royal Enterprises Manufacturing, Inc. on under FDA product code INI (Vehicle, Motorized 3-Wheeled). FDA records list 2 510(k) clearances for Royal Enterprises Manufacturing, Inc., from to . As of , FDA records show no recalls naming K881766.

Clearance record

Decision date
Received
(22 days to decision)
Product code
INI Vehicle, Motorized 3-Wheeled
Regulation
21 CFR 890.3800
Device class
Class II
Review panel
Physical Medicine
Applicant
Royal Enterprises Manufacturing, Inc. 3005 Perry St., Madison WI
Third party review
No

Clearances, product code INI

Trailing 12 months
24 clearances under product code INI in the twelve months to October 2026, January 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code INI, trailing twelve months
MonthClearances
November 20251
December 20252
January 20265
February 20262
March 20262
April 20261
May 20261
June 20262
July 20262
August 20262
September 20264
October 20260