Browse hierarchy: [Physical Medicine (PM)](/submissions/PM) → [Subpart F — Physical Medicine Therapeutic Devices](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices) → [21 CFR 890.5100](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5100) → ILM — Bath, Sitz, Powered

# ILM · Bath, Sitz, Powered

_Physical Medicine · 21 CFR 890.5100 · Class 2_

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

## Overview

- **Product Code:** ILM
- **Device Name:** Bath, Sitz, Powered
- **Regulation:** [21 CFR 890.5100](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5100)
- **Device Class:** 2
- **Review Panel:** [Physical Medicine](/submissions/PM)

## Identification

An immersion hydrobath is a device intended for medical purposes that consists of water agitators and that may include a tub to be filled with water. The water temperature may be measured by a gauge. It is used in hydrotherapy to relieve pain and itching and as an aid in the healing process of inflamed and traumatized tissue, and it serves as a setting for removal of contaminated tissue.

## Classification Rationale

Class II (special controls). The device, when it is a hydromassage bath or a powered sitz bath, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.

## Special Controls

*Classification.* Class II (special controls). The device, when it is a hydromassage bath or a powered sitz bath, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K953796](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILM/K953796.md) | BANKS HYDRO-THERAPY CHAIR | Keith Products, Inc. | Apr 1, 1996 | SESE |
| [K823327](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILM/K823327.md) | PORTABLE SHOWER BATH | Wall Manufacturer, Inc. | Dec 7, 1982 | SESE |

## Top Applicants

- Keith Products, Inc. — 1 clearance
- Wall Manufacturer, Inc. — 1 clearance

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

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