KTC · Bath, Sitz, Nonpowered
Physical Medicine · 21 CFR 890.5125 · Class 1
Overview
| Product Code | KTC |
|---|---|
| Device Name | Bath, Sitz, Nonpowered |
| Regulation | 21 CFR 890.5125 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
| GMP Exempt | Yes |
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.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K912179 | THE SPRITZ BATH | The Spritz Co. | Aug 28, 1991 | SESE |
| K890085 | SIT-N-BATHE SITZ BATH | Drummond Industries, Inc. | Feb 13, 1989 | SESE |
| K862600 | SITZ BATH | W. C. Green, D.D.S. | Jul 18, 1986 | SESE |
| K851309 | ABCO PLASTIC UTENSILS | Abco Dealers, Inc. | Jul 1, 1985 | SESE |
| K841711 | MAC LEE SITZ BATH | Mac Lee Medical Products | May 7, 1984 | SESE |
| K831762 | SITZ BATH, SINGLE PATIENT USE #8100 | Lsl Industries, Inc. | Jun 24, 1983 | SESE |
| K800958 | PERSONAL SITZ BATH KIT | The Healthcare Group Laboratories, Inc. | May 2, 1980 | SESE |
Top Applicants
- Abco Dealers, Inc. — 1 clearance
- Drummond Industries, Inc. — 1 clearance
- Lsl Industries, Inc. — 1 clearance
- Mac Lee Medical Products — 1 clearance
- The Healthcare Group Laboratories, Inc. — 1 clearance
