Cleared Traditional

MT-10, ET-20

K800251 · Associated Mills, Inc. · Physical Medicine
Apr 1980
Decision
56d
Days
Class 1
Risk

About This 510(k) Submission

K800251 is an FDA 510(k) clearance for the MT-10, ET-20, a Treadmill, Mechanical (Class I — General Controls, product code IOG), submitted by Associated Mills, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 2, 1980, 56 days after receiving the submission on February 6, 1980. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5370.

Submission Details

510(k) Number K800251 FDA.gov
FDA Decision Cleared SESE
Date Received February 06, 1980
Decision Date April 02, 1980
Days to Decision 56 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

Device Classification

Product Code IOG — Treadmill, Mechanical
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.5370