510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K040512Substantially Equivalent

Limited Function Wl/otc-TENS Device, Model Wl-2103A, Wl-2203A, Wl-2203B and Wl-2401

Well-Life Healthcare Limited, Madison TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K040512 is the FDA 510(k) clearance record for LIMITED FUNCTION WL/OTC-TENS DEVICE, MODEL WL-2103A, WL-2203A, WL-2203B AND WL-2401, a class II device, cleared for Well-Life Healthcare, Inc. on under FDA product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief). FDA records list 29 510(k) clearances for Well-Life Healthcare, Inc., from to . As of , FDA records show no recalls naming K040512.

Clearance record

Decision date
Received
(90 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
Well-Life Healthcare, Inc. 1109 Myatt Blvd., Madison TN
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