The Cradle

FDA 510(k) K933964 · The Primal Energy Research Foundation

Substantially Equivalent

510(k) numberK933964

Submission

Device name
The Cradle
Applicant
The Primal Energy Research Foundation
Houston, TX, US
Received
August 16, 1993
Decision date
October 3, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
IKZ – Bed, Patient Rotation, Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 890.5225
Specialty
Physical Medicine

Other 510(k)s with product code IKZ

510(k)DeviceApplicantDecision
K972486Pressureguard IVIKZ · Traditional Span-America Medical Systems, Inc.02/20/1998SE
K972111Rumors Dynamic Air Therapy UnitIKZ · Traditional Hill-Rom, Inc.02/02/1998SE
K962788Clinidyne Rotational Therapy Mattress SystemIKZ · Traditional Gaymar Industries, Inc.04/30/1997SE
K954671The Freedom BedIKZ · Traditional Probed Medical Technologies, Inc.04/01/1996SE
K950756Pulmonex Dynamic Air Therapy UnitIKZ · Traditional Hill-Rom, Inc.05/30/1995SE
K950681Model Turn Q Plus Automatic Turning Mattress with Low Air Loss TherapyIKZ · Traditional Invacare Corp.05/16/1995SE
K923710Oscillair 3000 Low Air Loss Kinetic Therapy BedIKZ · Traditional Progressive Medical Technology, Inc.03/22/1993SE
K922473Turn Ez Bed DeviceIKZ · Traditional Med-Ez, Inc.09/09/1992SE
K905390Kudo (Powered Rotation Bed)IKZ · Traditional Kinetic Concepts, Inc.01/08/1991SE
K905113Roto Rest; Trauma and Intensive Care BedIKZ · Traditional Ethos Medical Products , Ltd.11/26/1990SE

Questions and answers

When was The Cradle cleared by the FDA?

The Cradle (K933964) received a 510(k) decision of Substantially Equivalent on October 3, 1994, 413 days after the submission was received.

What is the product code of K933964?

The FDA product code is IKZ – Bed, Patient Rotation, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5225.