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510(k) K961621

THERAPY CONCEPTS WATER CIRCULATING TREATMENT SYSTEM by Therapy Concepts, Inc. — Product Code ILO

K961621 is an FDA 510(k) premarket notification submitted by Therapy Concepts, Inc. for the device "THERAPY CONCEPTS WATER CIRCULATING TREATMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on October 31, 1996. The device falls under product code ILO (Pack, Hot Or Cold, Water Circulating), a Class II device regulated under 21 CFR 890.5720.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1996
Date Received
April 26, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pack, Hot Or Cold, Water Circulating
Device Class
Class II
Regulation Number
890.5720
Review Panel
PM
Submission Type

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  • K964799 — ARTROTHERM CRYOTHERAPY AND THERNOTHERAPY (August 29, 1997)
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FDA data resources