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
K992874Substantially Equivalent

Q-Sweat Quantitative Sweat Measurement System

WR Medical Electronics Co., Stillwater MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K992874 is the FDA 510(k) clearance record for Q-SWEAT QUANTITATIVE SWEAT MEASUREMENT SYSTEM, a class II device, cleared for Wr Medical Electronics Co. on under FDA product code KTB (Device, Iontophoresis, Specific Uses). FDA records list 6 510(k) clearances for Wr Medical Electronics Co., from to . As of , FDA records show no recalls naming K992874.

Clearance record

Decision date
Received
(84 days to decision)
Product code
KTB Device, Iontophoresis, Specific Uses
Regulation
21 CFR 890.5525
Device class
Class II
Review panel
Physical Medicine
Applicant
Wr Medical Electronics Co. 123 #2nd.St., Stillwater MN
510(k) summary
Summary
Third party review
No

Clearances, product code KTB

Trailing 12 months

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

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