TotalCare Spot, Bariatric, Duo, DUO2 Bed System
FDA 510(k)Class II (US FDA 510(k))
by Hill-Rom
Identifiers
- 510(k) Number
- K122473 FDA 510(k)
- FDA Product Code
- IOQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.5170 FDA 510(k)
- Regulation Number
- 890.5170 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The TotalCare Bed System is a Bed, Flotation Therapy, Powered device, as classified under FDA product code IOQ. It incorporates powered mechanisms to adjust patient positioning and support, including flotation therapy features for enhanced comfort and mobility. The system is designed to accommodate a range of patient needs, including bariatric and standard weight patients, with varying weight capacities depending on the model.
This device is supplied as a reusable medical bed system, intended for use in clinical settings such as hospitals, rehabilitation centers, or long-term care facilities. It is not sterile at time of shipment and requires cleaning and maintenance per manufacturer guidelines. The system is regulated under FDA 510(k) clearance (K122473) and falls under Class II – Special Controls, adhering to regulatory requirements for powered patient support devices. Multiple model variants are authorized, each with distinct weight support specifications.
Frequently asked questions
What types of patients is the TotalCare Bed System designed to support, and how do the weight capacities differ between models?
The TotalCare Bed System is designed to accommodate both standard-weight and bariatric patients. The weight capacity varies depending on the specific model, with some variants supporting higher weight limits to meet bariatric needs. The system’s powered mechanisms and adjustable positioning ensure comfort and mobility for a range of patient sizes, making it suitable for clinical settings like hospitals, rehabilitation centers, and long-term care facilities.
Is the TotalCare Bed System intended for single-use or reusable applications, and what cleaning requirements apply?
The TotalCare Bed System is supplied as a reusable medical bed system and is not sterile at the time of shipment. It requires regular cleaning and maintenance following the manufacturer’s guidelines to ensure proper hygiene and functionality. This design aligns with its use in clinical environments where durability and repeated use are essential.
What regulatory pathway was followed for FDA clearance of the TotalCare Bed System, and what class does it fall under?
The TotalCare Bed System received FDA clearance through the 510(k) pathway, specifically under the Traditional review process, and is classified as a Class II device under Special Controls. It is categorized under product code IOQ as a Bed, Flotation Therapy, Powered, adhering to regulatory requirements for powered patient support devices in physical medicine.
How does the flotation therapy feature of the TotalCare Bed System enhance patient care, and in what settings is it commonly used?
The flotation therapy feature in the TotalCare Bed System provides enhanced comfort and mobility by utilizing powered mechanisms to adjust patient positioning. This helps reduce pressure points, improve circulation, and support recovery, making it particularly useful in settings like hospitals, rehabilitation centers, and long-term care facilities where patient mobility and comfort are critical.
Are there multiple model variants of the TotalCare Bed System, and how do they differ in terms of functionality or specifications?
Yes, the TotalCare Bed System includes multiple model variants, each authorized under the same FDA clearance (K122473). While the core functionality—powered positioning and flotation therapy—remains consistent, the variants likely differ in weight capacity, additional features, or specific design adaptations to better suit standard or bariatric patient needs. The exact distinctions would be detailed in the manufacturer’s specifications for each model.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Totalcare Spot Totalcare Bariatric Totalcare Duo Toatalcare Bed System ..., Totalcare Spot Totalcare Bariatric Totalcare Duo Toatalcare Bed System ..., K122473 FDA 510 (k) - TOTALCARE SPOT TOTALCARE BARIATRIC TOTA..., Total Care Bariatric Plus Bed Brochure - Hill-Rom
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K122473 | Class II | Active |
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Manufacturer
- Manufacturer
- Hill-Rom
Sources (1)
- FDA 510(k) K122473 24 fields · synced Oct 6, 2026