Cleared Traditional

CRAFTMATIC ELECTRIC ADJUSTABLE BED (K840787) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K840787 · Contour, Inc. · General Hospital
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Jun 1984
Decision
145d
Days
Class 2
Risk

K840787 is an FDA 510(k) clearance for the CRAFTMATIC ELECTRIC ADJUSTABLE BED. Classified as Bed, Therapeutic, Ac-powered, Adjustable Home-use (product code LLI), Class II - Special Controls.

Submitted by Contour, Inc. (Walker, US). The FDA issued a Cleared decision on June 13, 1984 after a review of 145 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5100 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Contour, Inc. devices

Submission Details

510(k) Number K840787 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 1984
Decision Date June 13, 1984
Days to Decision 145 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 129d · This submission: 145d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LLI Bed, Therapeutic, Ac-powered, Adjustable Home-use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5100
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 General Hospital devices follow this clearance model.