510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K853412Substantially Equivalent

Wave Gate

Wolfline Corp., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853412 is the FDA 510(k) clearance record for WAVE GATE, a class II device, cleared for Wolfline Corp. on under FDA product code GWE (Stimulator, Photic, Evoked Response). FDA records list one 510(k) clearance for Wolfline Corp. As of , FDA records show no recalls naming K853412.

Clearance record

Decision date
Received
(76 days to decision)
Product code
GWE Stimulator, Photic, Evoked Response
Regulation
21 CFR 882.1890
Device class
Class II
Review panel
Neurology
Applicant
Wolfline Corp. 5577 Honors Dr., San Diego CA
Third party review
No

Clearances, product code GWE

Trailing 12 months

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

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