PERSONAL SITZ BATH KIT
Device Facts
| Record ID | K800958 |
|---|---|
| Device Name | PERSONAL SITZ BATH KIT |
| Applicant | The Healthcare Group Laboratories, Inc. |
| Product Code | KTC · Physical Medicine |
| Decision Date | May 2, 1980 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5125 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A nonpowered sitz bath is a device intended for medical purposes that consists of a tub to be filled with water for use in external hydrotherapy to relieve pain or pruritis and to accelerate the healing of inflamed or traumatized tissues of the perianal and perineal areas.
