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) → LSB — Unit, Fluidotherapy

# LSB · Unit, Fluidotherapy

_Physical Medicine · 21 CFR 890.5100 · Class 2_

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

## Overview

- **Product Code:** LSB
- **Device Name:** Unit, Fluidotherapy
- **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 (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K011768](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LSB/K011768.md) | THERMO-THERAPY, MODELS TT-101, TT-201, AND TT-202 | Thermo-Electric Co. | Aug 3, 2001 | SESE |
| [K011243](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LSB/K011243.md) | CHATTANOOGA DRY HEAT WHIRLPOOL, MODEL 2000 | Chattanooga Group, Inc. | Jul 6, 2001 | SESE |
| [K896817](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LSB/K896817.md) | MODEL T11 FLUIDOTHERAPY UNIT | Henley Intl. | Jan 18, 1991 | SESE |
| [K871802](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LSB/K871802.md) | MODEL K210 AND K211 FLUIDOTHERAPY UNITS | Henley Intl. | Sep 4, 1987 | SESE |

## Top Applicants

- Henley Intl. — 2 clearances
- Chattanooga Group, Inc. — 1 clearance
- Thermo-Electric Co. — 1 clearance

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

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