510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K984565Substantially Equivalent

Tmc-Easy-302

Tmc Magnetics & Machinery Corp., Great Neck NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K984565 is the FDA 510(k) clearance record for TMC-EASY-302, a class II device, cleared for Tmc Magnetics & Machinery Corp. on under FDA product code INI (Vehicle, Motorized 3-Wheeled). FDA records list one 510(k) clearance for Tmc Magnetics & Machinery Corp. As of , FDA records show no recalls naming K984565.

Clearance record

Decision date
Received
(420 days to decision)
Product code
INI Vehicle, Motorized 3-Wheeled
Regulation
21 CFR 890.3800
Device class
Class II
Review panel
Physical Medicine
Applicant
Tmc Magnetics & Machinery Corp. 55 Northern Blvd., Great Neck NY
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