Cleared Traditional

MOTIVATOR FTR 2000

K942229 · Hogan & Hartson · Physical Medicine
Feb 1995
Decision
297d
Days
Class 2
Risk

About This 510(k) Submission

K942229 is an FDA 510(k) clearance for the MOTIVATOR FTR 2000, a System, Isokinetic Testing And Evaluation (Class II — Special Controls, product code IKK), submitted by Hogan & Hartson (Washington, US). The FDA issued a Cleared decision on February 27, 1995, 297 days after receiving the submission on May 6, 1994. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.1925.

Submission Details

510(k) Number K942229 FDA.gov
FDA Decision Cleared SESE
Date Received May 06, 1994
Decision Date February 27, 1995
Days to Decision 297 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