Cleared Traditional

K930261 - RTM REHABILITATION TREADMILL

K930261 is an FDA 510(k) clearance for RTM REHABILITATION TREADMILL, manufactured by Biodan Medical Systems, Ltd.. The device is a Class 1 Physical Medicine device with product code IOL cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K930261 · Biodan Medical Systems, Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1993
Decision
127d
Days
Class 1
Risk

K930261 is an FDA 510(k) clearance for the RTM REHABILITATION TREADMILL, MODEL #945-200. Classified as Treadmill, Powered (product code IOL), Class I - General Controls.

Submitted by Biodan Medical Systems, Ltd. (Shirley, US). The FDA issued a Cleared decision on May 26, 1993 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5380 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Biodan Medical Systems, Ltd. devices

FDA 510(k) Submission Details - K930261

510(k) Number K930261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 115d · This submission: 127d
Pathway characteristics
Predicate-based equivalence.

IOL Device Classification - Class 1, General Controls

Product Code IOL Treadmill, Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5380
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IOL Treadmill, Powered

All 20
Devices cleared under the same product code (IOL) and FDA review panel - the closest regulatory comparables to K930261.
MANSFIELD CARDIAC ASSIST MODEL 940(TM) IAB
K904556 · Boston Scientific Corp · Dec 1991
MEDTRACK TREADMILL
K911751 · Quinton, Inc. · May 1991
MODIFIED Q-SERIES OF TREADMILLS
K885062 · Quinton, Inc. · Dec 1988
MODEL Q55XT POWERED TREADMILL
K864013 · Quinton, Inc. · Nov 1986
MODIFIED Q50 MEDICAL TREADMILL
K863299 · Quinton, Inc. · Sep 1986
Q50 MEDICAL TREADMILL
K862741 · Quinton, Inc. · Jul 1986