MODEL T11 FLUIDOTHERAPY UNIT
Device Facts
| Record ID | K896817 |
|---|---|
| Device Name | MODEL T11 FLUIDOTHERAPY UNIT |
| Applicant | Henley Intl. |
| Product Code | LSB · Physical Medicine |
| Decision Date | Jan 18, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5100 |
| Device Class | Class 2 |
Regulatory Classification
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.
