Therapy Concepts Water Circulating Treatment System

FDA 510(k) K961621 · Therapy Concepts, Inc.

Substantially Equivalent

510(k) numberK961621

Submission

Device name
Therapy Concepts Water Circulating Treatment System
Applicant
Therapy Concepts, Inc.
Chesterfield, MO, US
Received
April 26, 1996
Decision date
October 31, 1996
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
ILO – Pack, Hot Or Cold, Water Circulating
Device class
Class II (moderate risk)
Regulation
21 CFR 890.5720
Specialty
Physical Medicine

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Questions and answers

When was Therapy Concepts Water Circulating Treatment System cleared by the FDA?

Therapy Concepts Water Circulating Treatment System (K961621) received a 510(k) decision of Substantially Equivalent on October 31, 1996, 188 days after the submission was received.

What is the product code of K961621?

The FDA product code is ILO – Pack, Hot Or Cold, Water Circulating, a Class II (moderate risk) device regulated under 21 CFR 890.5720.