510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K082065Substantially Equivalent

Well Life Self Adhesive Electrode / Models: Cm, Fa, Pu and Sp

Well-Life Healthcare Limited, Bonita Springs FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K082065 is the FDA 510(k) clearance record for WELL LIFE SELF ADHESIVE ELECTRODE / MODELS: CM, FA, PU AND SP, a class II device, cleared for Well-Life Healthcare Limited on under FDA product code GXY (Electrode, Cutaneous). FDA records list 29 510(k) clearances for Well-Life Healthcare Limited, from to . As of , FDA records show no recalls naming K082065.

Clearance record

Decision date
Received
(262 days to decision)
Product code
GXY Electrode, Cutaneous
Regulation
21 CFR 882.1320
Device class
Class II
Review panel
Neurology
Applicant
Well-Life Healthcare Limited 24301 Woodsage Dr., Bonita Springs FL
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