Home Care Water Flotation Bed HC4/TC/H

FDA 510(k) K840882 · Western Medical, Ltd.

Substantially Equivalent

510(k) numberK840882

Submission

Device name
Home Care Water Flotation Bed HC4/TC/H
Applicant
Western Medical, Ltd.
Mchenry, IL, US
Received
February 27, 1984
Decision date
July 18, 1984
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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Questions and answers

When was Home Care Water Flotation Bed HC4/TC/H cleared by the FDA?

Home Care Water Flotation Bed HC4/TC/H (K840882) received a 510(k) decision of Substantially Equivalent on July 18, 1984, 142 days after the submission was received.

What is the product code of K840882?

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