510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K883804Substantially Equivalent

E-Mitt (Conductive Hand Cover)

The Institute for Technology Development, Jackson MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K883804 is the FDA 510(k) clearance record for E-MITT (CONDUCTIVE HAND COVER), a class II device, cleared for The Institute For Technology Development on under FDA product code EAT (Tester, Pulp). FDA records list one 510(k) clearance for The Institute For Technology Development. As of , FDA records show no recalls naming K883804.

Clearance record

Decision date
Received
(327 days to decision)
Product code
EAT Tester, Pulp
Regulation
21 CFR 872.1720
Device class
Class II
Review panel
Dental
Applicant
The Institute For Technology Development Ummc-S.O.D., Suite 201, Jackson MI
Third party review
No

Clearances, product code EAT

Trailing 12 months

FDA records hold no clearances under product code EAT in the trailing twelve months.

FDA records show no clearances under product code EAT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EAT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260