Home Care Water Flotation Bed HC4/TC/H
510(k) K840882
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK840882 | Date18 Jul 1984 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- IOQ
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.5170
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Home Care Water Flotation Bed HC4/TC/H is a powered flotation therapy bed designed for physical medicine applications. It provides controlled buoyancy support to assist patients in reducing joint stress, improving mobility, and facilitating therapeutic exercises through immersion in water.
This device is supplied as a reusable medical product and is intended for use in home care settings. It has received FDA 510(k) clearance under the classification of Class II (IOQ product code) and is regulated under CFR Title 21, specifically 890.5170. The bed is not MRI-safe and requires proper storage and maintenance as outlined in the manufacturer’s instructions.
Other devices from Western Medical, Ltd.
Questions
AI-generated answers, 1 Oct 2026
What is the HC4/TC/H flotation bed designed for?
The HC4/TC/H flotation bed is specifically designed for physical medicine applications in home care settings. It provides controlled buoyancy support to help patients reduce joint stress, enhance mobility, and perform therapeutic exercises by immersing them in water. This makes it particularly useful for rehabilitation, pain management, and recovery from injuries or surgeries.
Is the HC4/TC/H flotation bed reusable or single-use?
The HC4/TC/H flotation bed is a reusable medical device. It is intended for repeated use in home care environments, provided it is properly maintained and cleaned according to the manufacturer’s instructions. Reusability ensures cost-effectiveness and sustainability while maintaining hygiene standards.
What regulatory approval does the HC4/TC/H flotation bed hold?
The HC4/TC/H flotation bed has received FDA 510(k) clearance under the classification of Class II, with the product code IOQ. This clearance indicates that the device is considered substantially equivalent to a legally marketed predicate device and is regulated under CFR Title 21, specifically 890.5170. The device is also associated with the Physical Medicine advisory committee.
Can the HC4/TC/H flotation bed be used in an MRI environment?
No, the HC4/TC/H flotation bed is not MRI-safe. If used in a facility with MRI capabilities, patients or caregivers must ensure the bed is not placed in the MRI scanning area or risk potential interference or safety hazards. Always follow the manufacturer’s guidelines for safe operation.
How should the HC4/TC/H flotation bed be stored?
The HC4/TC/H flotation bed requires proper storage to maintain its functionality and hygiene. It should be stored in a clean, dry environment, away from direct sunlight or extreme temperatures. Follow the manufacturer’s instructions for disassembly, cleaning, and storage to prevent damage, ensure longevity, and comply with regulatory standards for reusable medical devices.