Freedom Bath (K952442)
by Grand Traverse Technologies
510(k) K952442
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK952442 | Date2 Nov 1995 | 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- Withdrawn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
- Freedom 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, 1 Oct 2026
The Freedom Bath is a hydro-massage bath designed for physical medicine applications, classified as a Bath, Hydro-Massage under FDA product code ILJ. It incorporates integrated massage jets to provide therapeutic hydrotherapy, aiding in muscle relaxation, pain relief, and rehabilitation for patients with mobility or musculoskeletal conditions. The device is intended for use in clinical or home settings where hydrotherapy is prescribed as part of a treatment regimen.
This device is supplied as a reusable, non-sterile unit, intended for installation in fixed locations such as hospitals, rehabilitation centers, or private residences. It operates under standard electrical and plumbing connections, with dimensions of 36" x 55", including a 29-inch-wide seat and a swing-out door for accessibility. The Freedom Bath holds an FDA 510(k) clearance (K952442) under the Traditional 510(k) Review Process, classified as a Class II device (regulation number 890.5100). No MRI safety information is specified.
Questions
AI-generated answers, 1 Oct 2026
What is the Freedom Bath designed for?
The Freedom Bath is a hydro-massage bath intended for physical medicine applications. It provides therapeutic hydrotherapy through integrated massage jets, helping to relieve muscle tension, reduce pain, and support rehabilitation for patients with mobility or musculoskeletal conditions. It is suitable for use in both clinical settings like hospitals or rehabilitation centers and private residences where hydrotherapy is part of a prescribed treatment plan.
Is the Freedom Bath reusable or single-use?
The Freedom Bath is designed as a reusable unit. It is not intended for single-use and is meant to be installed in fixed locations such as hospitals, rehabilitation centers, or private homes. Its durable construction allows for repeated use over time, provided proper maintenance and cleaning protocols are followed.
What are the dimensions and accessibility features of the Freedom Bath?
The Freedom Bath measures 36 inches in width and 55 inches in length, with a seat width of 29 inches. It includes a swing-out door, which enhances accessibility for users. These features ensure the device can accommodate patients comfortably while providing ease of entry and exit.
How is the Freedom Bath supplied and installed?
The Freedom Bath is supplied as a reusable, non-sterile unit and requires installation in a fixed location. It operates using standard electrical and plumbing connections, meaning it must be connected to an existing water supply and electrical outlet. Installation should be performed by qualified professionals to ensure proper setup and safety.
Does the Freedom Bath have any specific storage requirements?
Since the Freedom Bath is a fixed-installation device, it does not require traditional storage like portable or mobile devices. However, it should be kept in a clean, dry environment when not in use to prevent damage or contamination. Regular maintenance, including cleaning and inspecting the jets and plumbing connections, is recommended to ensure optimal performance and longevity.