510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K943101Substantially Equivalent

Galvanic Skin Response Device

Global Ent., Orem UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K943101 is the FDA 510(k) clearance record for GALVANIC SKIN RESPONSE DEVICE, a class II device, cleared for Global Ent. on under FDA product code GZO (Device, Galvanic Skin Response Measurement). FDA records list one 510(k) clearance for Global Ent. As of , FDA records show no recalls naming K943101.

Clearance record

Decision date
Received
(476 days to decision)
Product code
GZO Device, Galvanic Skin Response Measurement
Regulation
21 CFR 882.1540
Device class
Class II
Review panel
Neurology
Applicant
Global Ent. 591 W. 1600 N., Suite 214, Orem UT
510(k) summary
Summary
Third party review
No

Clearances, product code GZO

Trailing 12 months

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

FDA records show no clearances under product code GZO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GZO, 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