Turbo

FDA 510(k) K912854 · Kinetic Concepts, Inc.

Substantially Equivalent

510(k) numberK912854

Submission

Device name
Turbo
Applicant
Kinetic Concepts, Inc.
San Antonio, TX, US
Received
June 28, 1991
Decision date
December 20, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

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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Questions and answers

When was Turbo cleared by the FDA?

Turbo (K912854) received a 510(k) decision of Substantially Equivalent on December 20, 1991, 175 days after the submission was received.

What is the product code of K912854?

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