LSB · Unit, Fluidotherapy
Physical Medicine · 21 CFR 890.5100 · Class 2
Overview
| Product Code | LSB |
|---|---|
| Device Name | Unit, Fluidotherapy |
| Regulation | 21 CFR 890.5100 |
| Device Class | Class 2 |
| Review Panel | Physical Medicine |
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 | THERMO-THERAPY, MODELS TT-101, TT-201, AND TT-202 | Thermo-Electric Co. | Aug 3, 2001 | SESE |
| K011243 | CHATTANOOGA DRY HEAT WHIRLPOOL, MODEL 2000 | Chattanooga Group, Inc. | Jul 6, 2001 | SESE |
| K896817 | MODEL T11 FLUIDOTHERAPY UNIT | Henley Intl. | Jan 18, 1991 | SESE |
| K871802 | 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
