Cleared Traditional

K951916 - CC RIDER, MODEL ME180

K951916 is an FDA 510(k) clearance for CC RIDER, manufactured by Mettler Electronics Corp.. The device is a Class 2 Physical Medicine device with product code IKK cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K951916 · Mettler Electronics Corp. · Physical Medicine device
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Oct 1995
Decision
163d
Days
Class 2
Risk

K951916 is an FDA 510(k) clearance for the CC RIDER, MODEL ME180. Classified as System, Isokinetic Testing And Evaluation (product code IKK), Class II - Special Controls.

Submitted by Mettler Electronics Corp. (Anaheim, US). The FDA issued a Cleared decision on October 4, 1995 after a review of 163 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 Mettler Electronics Corp. devices

FDA 510(k) Submission Details - K951916

510(k) Number K951916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1995
Decision Date October 04, 1995
Days to Decision 163 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d slower than avg
Panel avg: 115d · This submission: 163d
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 8
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