Cleared Traditional

QUINTON MEDTRACK CR PLUS TREADMILL

K990866 · Quinton, Inc. · Physical Medicine
Apr 1999
Decision
44d
Days
Class 2
Risk

About This 510(k) Submission

K990866 is an FDA 510(k) clearance for the QUINTON MEDTRACK CR PLUS TREADMILL, a Exerciser, Measuring (Class II — Special Controls, product code ISD), submitted by Quinton, Inc. (Bothell, US). The FDA issued a Cleared decision on April 29, 1999, 44 days after receiving the submission on March 16, 1999. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5360.

Submission Details

510(k) Number K990866 FDA.gov
FDA Decision Cleared SESE
Date Received March 16, 1999
Decision Date April 29, 1999
Days to Decision 44 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement

Device Classification

Product Code ISD — Exerciser, Measuring
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5360

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