Cleared Traditional

STAIRMASTER MODEL 6000 ERGOMETER

K912140 · Tri-Tech, Inc. · Physical Medicine
Dec 1991
Decision
217d
Days
Class 2
Risk

About This 510(k) Submission

K912140 is an FDA 510(k) clearance for the STAIRMASTER MODEL 6000 ERGOMETER, a Exerciser, Measuring (Class II — Special Controls, product code ISD), submitted by Tri-Tech, Inc. (Fort Woth, US). The FDA issued a Cleared decision on December 17, 1991, 217 days after receiving the submission on May 14, 1991. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5360.

Submission Details

510(k) Number K912140 FDA.gov
FDA Decision Cleared SESE
Date Received May 14, 1991
Decision Date December 17, 1991
Days to Decision 217 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

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

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