# K972111: Rumors Dynamic Air Therapy Unit

- Pathway: 510(k) (Traditional)
- Applicant: Hill-Rom, Inc.
- Decided: Feb 2, 1998 after 242 days
- Product code: IKZ (Bed, Patient Rotation, Powered)
- Device class: 2
- Regulation: 21 CFR 890.5225
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) EFICA CC® Dynamic Air Therapy® Unit manufactured by Hill-Rome: named in the summary without a submission number
- (no number) PULMONEX™ Dynamic Air Therapy® Unit manufactured by Hill-Rome: named in the summary without a submission number
- (no number) SYNERGY F.A.S.T. manufactured by Cardio Systems: named in the summary without a submission number
- (no number) TriaDyne™ Critical Care Healing System manufactured by KCI Therapeutic Services: named in the summary without a submission number

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

## Indications for use
The RUMORS Dynamic Air Therapy® Unit is intended to be used to treat or prevent pulmonary complications associated with immobility; to treat or prevent pressure ulcers; or for any other use where medical benefits may be derived from Continuous Lateral Rotation Therapy.

Source page: https://510kreport.com/device/K972111
Methodology: https://510kreport.com/methodology