Cleared Traditional

K123746 - AMES THERAPY DEVICE

K123746 is an FDA 510(k) clearance for AMES THERAPY DEVICE, manufactured by Ames Technology, Inc.. The device is a Class 2 Physical Medicine device with product code IKK cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K123746 · Ames Technology, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
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May 2013
Decision
169d
Days
Class 2
Risk

K123746 is an FDA 510(k) clearance for the AMES THERAPY DEVICE. Classified as System, Isokinetic Testing And Evaluation (product code IKK), Class II - Special Controls.

Submitted by Ames Technology, Inc. (Eugene, US). The FDA issued a Cleared decision on May 24, 2013 after a review of 169 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 Ames Technology, Inc. devices

FDA 510(k) Submission Details - K123746

510(k) Number K123746 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2012
Decision Date May 24, 2013
Days to Decision 169 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 115d · This submission: 169d
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
Devices cleared under the same product code (IKK) and FDA review panel - the closest regulatory comparables to K123746.
CC RIDER, MODEL ME180
K951916 · Mettler Electronics Corp. · Oct 1995
MOTIVATOR FTR 2000
K942229 · Hogan & Hartson · Feb 1995
CLOSED CHAIN ATTACHMENT, MODEL #820-520
K923350 · Biodan Medical Systems, Ltd. · Jul 1992
TWO POSITION ROLL-UP BACK ATTACHMENT CHAIR
K922772 · Biodan Medical Systems, Ltd. · Jul 1992
SINGLE CHAIR INTEGRAL BACK ATTACHMENT
K922092 · Biodan Medical Systems, Ltd. · May 1992
KIN-COM ASYMMETRICAL BACK SYSTEM
K911805 · Chattanooga Group, Inc. · Jul 1991