Cleared Traditional

K950095 - CYBEX 770

K950095 is an FDA 510(k) clearance for CYBEX 770, 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 162-day FDA review.

K950095 · Cybex · Physical Medicine device
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Jun 1995
Decision
162d
Days
Class 2
Risk

K950095 is an FDA 510(k) clearance for the CYBEX 770. 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 June 21, 1995 after a review of 162 days - an extended review cycle.

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.

View all Cybex devices

FDA 510(k) Submission Details - K950095

510(k) Number K950095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1995
Decision Date June 21, 1995
Days to Decision 162 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
47d slower than avg
Panel avg: 115d · This submission: 162d
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.

Regulatory Peers - IKK System, Isokinetic Testing And Evaluation

All 9
Devices cleared under the same product code (IKK) and FDA review panel - the closest regulatory comparables to K950095.
AMES THERAPY DEVICE
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K922772 · Biodan Medical Systems, Ltd. · Jul 1992
SINGLE CHAIR INTEGRAL BACK ATTACHMENT
K922092 · Biodan Medical Systems, Ltd. · May 1992