Liberty Immers Hydro Bath
by Unique Bathing Supplies, Inc.
510(k) K902603
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK902603 | Date29 Jun 1990 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Liberty, Freedom & Independence Immers Hydro Bath
- 510(k) Number
- FDA Product Code
- ILJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.5100
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Liberty Immers Hydro Bath is a hydro-massage bath designed for physical medicine applications. Classified as a hydro-massage bath under FDA product code ILJ, it incorporates water agitators and a tub for filling with water, often including a temperature gauge to monitor therapeutic conditions. This device is intended for hydrotherapy to alleviate pain and itching while aiding the healing of inflamed or affected areas.
Supplied as a reusable device, the Liberty Immers Hydro Bath is regulated under 21 CFR 890.5100 and granted FDA 510(k) clearance (K902603) as substantially equivalent to a predicate device. It is intended for use in clinical settings such as physical medicine and rehabilitation, with no specific sterility requirements stated. The device is manufactured by Unique Bathing Supplies, Inc., and falls under Class II regulatory classification.
Questions
AI-generated answers, 19 Sep 2026
What clinical applications is the Liberty Immers Hydro Bath primarily used for in physical medicine settings?
The Liberty Immers Hydro Bath is designed for hydrotherapy to help alleviate pain and itching while promoting the healing of inflamed or affected areas. It is specifically intended for use in physical medicine and rehabilitation, where water agitation and temperature control are used therapeutically.
Is the Liberty Immers Hydro Bath a single-use or reusable device, and what does that mean for maintenance?
The Liberty Immers Hydro Bath is a reusable device, meaning it is built to be used repeatedly in clinical settings. Since it is not sterile by design, proper cleaning and maintenance protocols must be followed between uses to ensure hygiene and functionality, particularly in physical medicine applications.
How is the Liberty Immers Hydro Bath regulated, and what does its FDA clearance status indicate?
The Liberty Immers Hydro Bath received FDA 510(k) clearance (K902603) under product code ILJ, classified as a hydro-massage bath. This clearance indicates it is deemed substantially equivalent to a predicate device and falls under Class II regulatory classification, governed by 21 CFR 890.5100. It is intended for use in physical medicine and rehabilitation.
Does the Liberty Immers Hydro Bath come with any specific features to monitor therapeutic conditions during use?
Yes, the Liberty Immers Hydro Bath includes a temperature gauge, which allows clinicians to monitor and maintain therapeutic water conditions during hydrotherapy sessions. This feature helps ensure consistent and effective treatment for pain relief and healing.
What types of facilities or settings is this device typically used in, and why?
The Liberty Immers Hydro Bath is designed for clinical settings such as physical medicine and rehabilitation facilities. Its hydro-massage and temperature control features make it suitable for therapeutic applications where water-based treatments are used to manage pain, itching, and inflammation in patients.