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U.S. Department of Health and Human Services

Product Classification
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Device water immersion labor pool
Definition Partial water immersion during labor in hospitals, birth centers and home.
Physical State Labor pools/tubs are structures intended to hold water which may be heated. They may be portable structures which are inflated or easily assembled which are filled using a hose or fixed structures which make use of fixed plumbing. They may be for single patient use or for multiple users.
Technical Method The pool/tub provides a water environment in which a pregnant woman may labor.
Target Area Area below the head.
Review Panel Obstetrics/Gynecology
Product CodeOVX
Premarket Review Reproductive, Gynecology and Urology Devices (DHT3B)
Reproductive, Gynecology and Urology Devices (DHT3B)
Not Classified Reason Enforcement Discretion
Submission Type Enforcement Discretion
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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