510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K961621Substantially Equivalent

Therapy Concepts Water Circulating Treatment System

Therapy Concepts, Inc., Chesterfield MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K961621 is the FDA 510(k) clearance record for THERAPY CONCEPTS WATER CIRCULATING TREATMENT SYSTEM, a class II device, cleared for Therapy Concepts, Inc. on under FDA product code ILO (Pack, Hot Or Cold, Water Circulating). FDA records list one 510(k) clearance for Therapy Concepts, Inc. As of , FDA records show no recalls naming K961621.

Clearance record

Decision date
Received
(188 days to decision)
Product code
ILO Pack, Hot Or Cold, Water Circulating
Regulation
21 CFR 890.5720
Device class
Class II
Review panel
Physical Medicine
Applicant
Therapy Concepts, Inc. 15 Foxhunt Dr., Chesterfield MO
510(k) summary
Summary
Third party review
No

Clearances, product code ILO

Trailing 12 months

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

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