Cleared Traditional

RTM REHABILITATION TREADMILL, MODEL #945-200

K930261 · Biodan Medical Systems, Ltd. · Physical Medicine
May 1993
Decision
127d
Days
Class 1
Risk

About This 510(k) Submission

K930261 is an FDA 510(k) clearance for the RTM REHABILITATION TREADMILL, MODEL #945-200, a Treadmill, Powered (Class I — General Controls, product code IOL), submitted by Biodan Medical Systems, Ltd. (Shirley, US). The FDA issued a Cleared decision on May 26, 1993, 127 days after receiving the submission on January 19, 1993. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5380.

Submission Details

510(k) Number K930261 FDA.gov
FDA Decision Cleared SESE
Date Received January 19, 1993
Decision Date May 26, 1993
Days to Decision 127 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code IOL — Treadmill, Powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.5380