← Product Code [KTC](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/KTC) · K831762

# SITZ BATH, SINGLE PATIENT USE #8100 (K831762)

_Lsl Industries, Inc. · KTC · Jun 24, 1983 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/KTC/K831762

## Device Facts

- **Applicant:** Lsl Industries, Inc.
- **Product Code:** [KTC](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/KTC.md)
- **Decision Date:** Jun 24, 1983
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.5125
- **Device Class:** Class 1
- **Review Panel:** Physical Medicine

## Regulatory 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.

---

**Source:** [https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/KTC/K831762](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/KTC/K831762)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com