# K970636: Totalcare., Modular Therapy System (MTS)

- Pathway: 510(k) (Traditional)
- Applicant: Hill-Rom, Inc.
- Decided: Aug 26, 1997 after 187 days
- Product code: IOQ (Bed, Flotation Therapy, Powered)
- Device class: 2
- Regulation: 21 CFR 890.5170
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K945729 (1995). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951001: Flexicair Exlipse, Hill-Rom, Inc. (1995) Summary page 1.
- K945729: Dynamicaire (TM) Sleep Surface, Zoneair (TM) Sleep Surface, Hill-Rom, Inc. (1995) Summary page 1.

## Most influential descendants
- K122473: Totalcare Spot Totalcare Bariatric Totalcare Duo Toatalcare Bed System Totalcare DUO2 (2013), 0 descendants of its own

## Recalls of this device
- Feb 26, 2013 · Class II · Z-0949-2013: In certain situations a software problem with the TotalCare SpO2RT 2 bed may occur that can lead to inadvertent loss of sufficient surface cushion pressure to adequately support the patient. This may 

## Indications for use
The product is a device intended for medical purposes that consists of a mattress and a control unit which provides automatic changes in distribution and control of interface pressure. It is used to prevent and treat conditions where reduction of interface pressure is beneficial. The device is intended to provide a patient surface suitable for use with the general patient population in a variety of health care environments as determined appropriate by health care professionals. The TotalCare.. Modular Therapy System (MTS) is intended to be used in conjunction with the TotalCare. Patient Support System (PSS). The MTS is not intended for use with patients with unstable cervical fractures.

Source page: https://510kreport.com/device/K970636
Methodology: https://510kreport.com/methodology