Cleared Traditional

AMES THERAPY DEVICE

K123746 · Ames Technology, Inc. · Physical Medicine
May 2013
Decision
169d
Days
Class 2
Risk

About This 510(k) Submission

K123746 is an FDA 510(k) clearance for the AMES THERAPY DEVICE, a System, Isokinetic Testing And Evaluation (Class II — Special Controls, product code IKK), submitted by Ames Technology, Inc. (Eugene, US). The FDA issued a Cleared decision on May 24, 2013, 169 days after receiving the submission on December 6, 2012. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.1925.

Submission Details

510(k) Number K123746 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code IKK — System, Isokinetic Testing And Evaluation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.1925