510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K001835Substantially Equivalent

Irv2000 Individual Recreational Vehicle

Trac About, Inc., Lakewood CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K001835 is the FDA 510(k) clearance record for IRV2000 INDIVIDUAL RECREATIONAL VEHICLE, a class II device, cleared for Trac About, Inc. on under FDA product code INI (Vehicle, Motorized 3-Wheeled). FDA records list one 510(k) clearance for Trac About, Inc. As of , FDA records show no recalls naming K001835.

Clearance record

Decision date
Received
(117 days to decision)
Product code
INI Vehicle, Motorized 3-Wheeled
Regulation
21 CFR 890.3800
Device class
Class II
Review panel
Physical Medicine
Applicant
Trac About, Inc. 777 S. Wadsworth Blvd., Lakewood CO
510(k) summary
Statement
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