Cleared Traditional

K840881 - WATER FLOATION BED 800/TC/H

K840881 is an FDA 510(k) clearance for WATER FLOATION BED 800/TC/H, manufactured by Western Medical, Ltd.. The device is a Class 2 Physical Medicine device with product code IOQ cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K840881 · Western Medical, Ltd. · Physical Medicine device
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Jul 1984
Decision
142d
Days
Class 2
Risk

K840881 is an FDA 510(k) clearance for the WATER FLOATION BED 800/TC/H. Classified as Bed, Flotation Therapy, Powered (product code IOQ), Class II - Special Controls.

Submitted by Western Medical, Ltd. (Walker, US). The FDA issued a Cleared decision on July 18, 1984 after a review of 142 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5170 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Western Medical, Ltd. devices

FDA 510(k) Submission Details - K840881

510(k) Number K840881 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1984
Decision Date July 18, 1984
Days to Decision 142 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 115d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IOQ Device Classification - Class 2, Special Controls

Product Code IOQ Bed, Flotation Therapy, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5170
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.