SITZ BATH, SINGLE PATIENT USE #8100
Device Facts
| Record ID | K831762 |
|---|---|
| Device Name | SITZ BATH, SINGLE PATIENT USE #8100 |
| Applicant | Lsl Industries, Inc. |
| Product Code | KTC · Physical Medicine |
| Decision Date | Jun 24, 1983 |
| 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.