510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K162460Substantially Equivalent

WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode Contacts

Wavi Co., Englewood CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K162460 is the FDA 510(k) clearance record for WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode Contacts, a class II device, cleared for Wavi Co. on under FDA product code GXY (Electrode, Cutaneous). FDA records list one 510(k) clearance for Wavi Co. As of , FDA records show no recalls naming K162460.

Clearance record

Decision date
Received
(238 days to decision)
Product code
GXY Electrode, Cutaneous
Regulation
21 CFR 882.1320
Device class
Class II
Review panel
Neurology
Applicant
Wavi Co. 3535 S. Irving St., Englewood CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GXY

Trailing 12 months
11 clearances under product code GXY in the twelve months to October 2026, May 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code GXY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20261
April 20262
May 20263
June 20262
July 20261
August 20261
September 20260
October 20260