510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K926136Substantially Equivalent

Watsystem

Watsystem Div. of Itc, Bloomington IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K926136 is the FDA 510(k) clearance record for WATSYSTEM, a class I device, cleared for Watsystem Div. of Itc on under FDA product code BXB (Exerciser, Powered). FDA records list one 510(k) clearance for Watsystem Div. of Itc. As of , FDA records show no recalls naming K926136.

Clearance record

Decision date
Received
(529 days to decision)
Product code
BXB Exerciser, Powered
Regulation
21 CFR 890.5380
Device class
Class I
Review panel
Physical Medicine
Applicant
Watsystem Div. of Itc 2425 S. Main, Bloomington IL
510(k) summary
Statement
Third party review
No

Clearances, product code BXB

Trailing 12 months

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

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