Cleared Traditional

HYDRA TRED DC

K801250 · Medichanics, Inc. · Physical Medicine
Jun 1980
Decision
20d
Days
Class 1
Risk

About This 510(k) Submission

K801250 is an FDA 510(k) clearance for the HYDRA TRED DC, a Treadmill, Mechanical (Class I — General Controls, product code IOG), submitted by Medichanics, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 17, 1980, 20 days after receiving the submission on May 28, 1980. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5370.

Submission Details

510(k) Number K801250 FDA.gov
FDA Decision Cleared SESE
Date Received May 28, 1980
Decision Date June 17, 1980
Days to Decision 20 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