ILM · Bath, Sitz, Powered
Physical Medicine · 21 CFR 890.5100 · Class 2
Overview
| Product Code | ILM |
|---|---|
| Device Name | Bath, Sitz, Powered |
| 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 (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K953796 | BANKS HYDRO-THERAPY CHAIR | Keith Products, Inc. | Apr 1, 1996 | SESE |
| K823327 | PORTABLE SHOWER BATH | Wall Manufacturer, Inc. | Dec 7, 1982 | SESE |
Top Applicants
- Keith Products, Inc. — 1 clearance
- Wall Manufacturer, Inc. — 1 clearance
