Cleared Traditional

K926402 - COMFORT CARE LOW AIR LOSS THERAPY BED

K926402 is an FDA 510(k) clearance for COMFORT CARE LOW AIR LOSS THERAPY BED, manufactured by Ch Administration, Inc.. The device is a Class 2 Physical Medicine device with product code INX cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K926402 · Ch Administration, Inc. · Physical Medicine device
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Mar 1993
Decision
93d
Days
Class 2
Risk

K926402 is an FDA 510(k) clearance for the COMFORT CARE LOW AIR LOSS THERAPY BED. Classified as Bed, Air Fluidized (product code INX), Class II - Special Controls.

Submitted by Ch Administration, Inc. (Dallas, US). The FDA issued a Cleared decision on March 24, 1993 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5160 - 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 Ch Administration, Inc. devices

FDA 510(k) Submission Details - K926402

510(k) Number K926402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1992
Decision Date March 24, 1993
Days to Decision 93 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 115d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

INX Device Classification - Class 2, Special Controls

Product Code INX Bed, Air Fluidized
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5160
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.

Regulatory Peers - INX Bed, Air Fluidized

Devices cleared under the same product code (INX) and FDA review panel - the closest regulatory comparables to K926402.
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