Cleared Traditional

K914851 - CLA-1400 SYSTEM

K914851 is the FDA 510(k) clearance for CLA-1400 SYSTEM by Gaymar Industries, Inc.. It is a Class 2 Physical Medicine device (product code IOQ) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K914851 · Gaymar Industries, Inc. · Physical Medicine device
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Nov 1991
Decision
16d
Days
Class 2
Risk

K914851 is an FDA 510(k) clearance for the CLA-1400 SYSTEM. Classified as Bed, Flotation Therapy, Powered (product code IOQ), Class II - Special Controls.

Submitted by Gaymar Industries, Inc. (Orchard Park, US). The FDA issued a Cleared decision on November 13, 1991 after a review of 16 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Gaymar Industries, Inc. devices

Submission Details

510(k) Number K914851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1991
Decision Date November 13, 1991
Days to Decision 16 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 115d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.

Regulatory Peers - IOQ Bed, Flotation Therapy, Powered

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