# K122473: Totalcare Spot Totalcare Bariatric Totalcare Duo Toatalcare Bed System Totalcare DUO2

- Pathway: 510(k) (Traditional)
- Applicant: Hill-Rom
- Decided: Jun 3, 2013 after 293 days
- Product code: IOQ (Bed, Flotation Therapy, Powered)
- Device class: 2
- Regulation: 21 CFR 890.5170
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K925529 (1993). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103536: Ibed Wireless with Ibed Awareness, Stryker Corporation (2010) Summary page 1.
- K962942: Totalcare, Hill-Rom, Inc. (1997) Summary page 1.
- K970636: Totalcare., Modular Therapy System (MTS), Hill-Rom, Inc. (1997) Summary page 1.
- K972111: Rumors Dynamic Air Therapy Unit, Hill-Rom, Inc. (1998) Summary page 1.

## Recalls of this device
- Feb 25, 2025 · Class II · Z-1468-2025: The air bladders inside the mattress may move out of position when the head of the bed is elevated, causing a dip in the mattress.
- Oct 4, 2023 · Class II · Z-0212-2024: Progressa+ beds have the potential for static buildup from the casters and/or power drive. This static electricity could be passed to the operator through the transport handle during transport, result

## Indications for use
The TotalCare® Bed System is intended to be used to treat or prevent pulmonary or other complications associated with immobility; to treat or prevent pressure ulcers; or for any other use where medical benefits may be derived from either Continuous Lateral Rotation Therapy or Percussion/Vibration Therapy. The TotalCare® Bed System is intended fo provide a patient support to be used in health care environments. The TotalCare® Bed System may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sections of the emergency department (ED). The TotalCare® Bed System is capable of being used with a broad patient population as determined appropriate by the caregiver or institution. The TotalCare® Bed System, dependent upon model, is capable of supporting patient populations up to 500 ibs.

Source page: https://510kreport.com/device/K122473
Methodology: https://510kreport.com/methodology