TotalCare Modular Therapy System (MTS)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K970636 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 Modular Therapy System (MTS) is a Bed, Flotation Therapy, Powered designed for patient support and therapeutic intervention. It features a microprocessor-controlled air system with proportional air valves to adjust flotation and pressure distribution across a modular mattress surface. This modular design enables customisation of therapy options to accommodate varying patient needs, including pressure relief and positioning support.
The system is supplied as a reusable medical device intended for use in clinical settings such as hospitals and rehabilitation centres. It is classified under FDA product code IOQ and has received FDA 510(k) clearance under the Traditional review pathway. The modular mattress components are engineered for durability and compatibility with the integrated air management system, ensuring consistent performance across multiple configurations. No sterility claims are specified, and MRI safety is not addressed in the available data.
Frequently asked questions
What is the TotalCare Modular Therapy System (MTS) used for?
The TotalCare Modular Therapy System (MTS) is designed for patient support and therapeutic intervention in clinical environments. Its microprocessor-controlled air system with proportional air valves enables precise adjustment of flotation and pressure distribution across a modular mattress surface. This customisation helps address varying patient needs, such as pressure relief and positioning support, making it suitable for hospitals and rehabilitation centres.
Is the TotalCare Modular Therapy System (MTS) reusable or single-use?
The TotalCare Modular Therapy System (MTS) is explicitly supplied as a reusable medical device. It is engineered for durability and compatibility with the integrated air management system, ensuring consistent performance across multiple uses in clinical settings. There are no sterility claims specified for this device.
How does the modular design of the MTS benefit patients?
The modular design of the TotalCare Modular Therapy System (MTS) allows healthcare providers to customise therapy options based on individual patient needs. This adaptability supports varying requirements for pressure relief and positioning, enhancing comfort and therapeutic outcomes. The modular mattress components are engineered to work seamlessly with the air management system, ensuring flexibility and consistency across different configurations.
What regulatory pathway was followed for the FDA clearance of the MTS?
The TotalCare Modular Therapy System (MTS) received FDA 510(k) clearance under the Traditional review pathway. It is classified under product code IOQ and was determined to be substantially equivalent to a predicate device. The clearance was granted by the Physical Medicine (PM) advisory committee, reflecting its intended use in therapeutic patient support.
Are there any specific safety considerations mentioned for the MTS?
The available data for the TotalCare Modular Therapy System (MTS) does not address MRI safety or specify any sterility claims. Clinicians should follow standard protocols for reusable medical devices, including proper cleaning and maintenance, to ensure safe and effective use in clinical settings.
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., MODULAR THERAPY SYSTEM (MTS) by HILL-ROM, INC. | FDA 510 (k ..., TOTALCARE., MODULAR THERAPY SYSTEM (MTS) (K970636) — FDA 510 (k ..., K970636 FDA 510 (k) - TOTALCARE. | Hill-Rom, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K970636 | Class II | Active |
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Manufacturer
- Manufacturer
- Hill-Rom, Inc.
Sources (1)
- FDA 510(k) K970636 24 fields · synced Oct 1, 2026