← Product Code [ILJ](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILJ) · K930624

# SANITAS WHIRPOOL BATHING SYSTEM (K930624)

_Dutton-Lainson Co. · ILJ · Jul 1, 1994 · Physical Medicine · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILJ/K930624

## Device Facts

- **Applicant:** Dutton-Lainson Co.
- **Product Code:** [ILJ](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILJ.md)
- **Decision Date:** Jul 1, 1994
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 890.5100
- **Device Class:** Class 2
- **Review Panel:** Physical Medicine

## Regulatory 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.

## 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.

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**Source:** [https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILJ/K930624](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ILJ/K930624)

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