510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K840472Substantially Equivalent

Sys Macroduct Sweat Collection Sys 3600

ELITechGroup Inc, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K840472 is the FDA 510(k) clearance record for SYS MACRODUCT SWEAT COLLECTION SYS 3600, a class II device, cleared for Wescor, Inc. on under FDA product code KTB (Device, Iontophoresis, Specific Uses). FDA records list 32 510(k) clearances for ELITechGroup Inc, from to . As of , FDA records show no recalls naming K840472.

Clearance record

Decision date
Received
(45 days to decision)
Product code
KTB Device, Iontophoresis, Specific Uses
Regulation
21 CFR 890.5525
Device class
Class II
Review panel
Physical Medicine
Applicant
Wescor, Inc. 4221 Richmond Rd., NW, Walker MI
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