510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K963507Substantially Equivalent

Extra TENS (Ri-2500) Neo TENS (Ri-2000E)

Comtek Intl., Corp., Commack NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963507 is the FDA 510(k) clearance record for EXTRA TENS (RI-2500) NEO TENS (RI-2000E), a class II device, cleared for Comtek Intl., Corp. on under FDA product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief). FDA records list one 510(k) clearance for Comtek Intl., Corp. As of , FDA records show no recalls naming K963507.

Clearance record

Decision date
Received
(197 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
Comtek Intl., Corp. 2 Gamay Ct., Commack NY
510(k) summary
Statement
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