510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K080304Substantially Equivalent

Pro TENS, Model Wl-240 Rx

Well-Life Healthcare Limited, Yunghe City, Taipei County, TW / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080304 is the FDA 510(k) clearance record for PRO TENS, MODEL WL-240 RX, a class II device, cleared for Well-Life Healthcare Limited on under FDA product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief). FDA records list 29 510(k) clearances for Well-Life Healthcare Limited, from to . As of , FDA records show no recalls naming K080304.

Clearance record

Decision date
Received
(136 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 Limited 1fl, #16, Ln. 454, Yunghe City, Taipei County, TW
510(k) summary
Summary PDF
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