Cleared Traditional

K844368 - LINEAR LIFT DEVICE

K844368 is an FDA 510(k) clearance for LINEAR LIFT DEVICE, manufactured by Cybex. The device is a Class 2 Physical Medicine device with product code IKK cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K844368 · Cybex · Physical Medicine device
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Feb 1985
Decision
98d
Days
Class 2
Risk

K844368 is an FDA 510(k) clearance for the LINEAR LIFT DEVICE. Classified as System, Isokinetic Testing And Evaluation (product code IKK), Class II - Special Controls.

Submitted by Cybex (Ronkonkoma, US). The FDA issued a Cleared decision on February 19, 1985 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.1925 - 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.

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FDA 510(k) Submission Details - K844368

510(k) Number K844368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1984
Decision Date February 19, 1985
Days to Decision 98 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
17d faster than avg
Panel avg: 115d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IKK Device Classification - Class 2, Special Controls

Product Code IKK System, Isokinetic Testing And Evaluation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.1925
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.