510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K812612Substantially Equivalent

Tns Mk I Stimulator

Edu Kit, Ltd., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K812612 is the FDA 510(k) clearance record for TNS MK I STIMULATOR, a class II device, cleared for Edu Kit , Ltd. on under FDA product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief). FDA records list one 510(k) clearance for Edu Kit , Ltd. As of , FDA records show no recalls naming K812612.

Clearance record

Decision date
Received
(156 days to decision)
Product code
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Regulation
21 CFR 882.5890
Device class
Class II
Review panel
Neurology
Applicant
Edu Kit , Ltd. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code GZJ

Trailing 12 months
2 clearances under product code GZJ in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GZJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260