Definition: Partial Water Immersion During Labor In Hospitals, Birth Centers And Home.
| Device Type ID | 4127 |
| Device Name | Water Immersion Labor Pool |
| 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 Sin |
| 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 |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Obstetrics And Gynecology Devices Branch (OGDB) |
| Submission Type | Enforcement Discretion |
| FDA Device Classification | Class Not Classified Medical Device |
| Product Code | OVX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4127 |
| Device | Water Immersion Labor Pool |
| Product Code | OVX |