Last synced on 27 January 2023 at 11:04 pm

Water Immersion Labor Pool

Page Type
Product Code
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
Obstetrical and Gynecological
Submission Type
Enforcement Discretion
Device Classification
N
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

As product code OVX is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.

Water Immersion Labor Pool

Page Type
Product Code
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
Obstetrical and Gynecological
Submission Type
Enforcement Discretion
Device Classification
N
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

As product code OVX is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.