Ultraflotation Bed

FDA 510(k) K882607 · Medical Flotation Systems, Inc.

Substantially Equivalent

510(k) numberK882607

Submission

Device name
Ultraflotation Bed
Applicant
Medical Flotation Systems, Inc.
Herndon, VA, US
Received
June 24, 1988
Decision date
October 14, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
IOQ – Bed, Flotation Therapy, Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 890.5170
Specialty
Physical Medicine

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K973624Nurse's Aid Patient Rotation SystemIOQ · Traditional Air Med Assist Products01/21/1998SE
K970364AIRTEC2 Low Air Loss Therapy BedIOQ · Traditional Apex Metal, Inc.11/17/1997SE
K970363Hydrotec Low Air Loss Therapy BedIOQ · Traditional Apex Metal, Inc.11/17/1997SE
K970636Totalcare., Modular Therapy System (MTS)IOQ · Traditional Hill-Rom, Inc.08/26/1997SE
K964873Silkair Low Airloss TherapyIOQ · Traditional Hill-Rom, Inc.07/03/1997SE
K970295Flexicair Exlipse PlusIOQ · Traditional Hill-Rom, Inc.05/16/1997SE
K943433Total Contact Seat Ripple SystemIOQ · Traditional Numotech, Inc.07/31/1995SE
K951001Flexicair ExlipseIOQ · Traditional Hill-Rom, Inc.06/27/1995SE

More from Hill-Rom, Inc.

510(k)DeviceDecision
K893801M.F.S. Low Air Loss Pulsating BedIOQ · Traditional 07/25/1989SE
K890200Pneumatic DorsiflexorBXB · Traditional 02/03/1989SE
K884908Ultraflotation Medical WheelchairINF · Traditional 12/27/1988SE
K884907Bumpy Medical Massage MatLYG · Traditional 12/27/1988SE

Questions and answers

When was Ultraflotation Bed cleared by the FDA?

Ultraflotation Bed (K882607) received a 510(k) decision of Substantially Equivalent on October 14, 1988, 112 days after the submission was received.

What is the product code of K882607?

The FDA product code is IOQ – Bed, Flotation Therapy, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5170.