Cleared Traditional

THE BLEDSOE PASSIVE MOTION EXERCISER (K854354) - FDA 510(k) Clearance

Class I Physical Medicine device.

K854354 · Medical Technology and Innovations, Inc. · Physical Medicine device
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Feb 1986
Decision
100d
Days
Class 1
Risk

K854354 is an FDA 510(k) clearance for the THE BLEDSOE PASSIVE MOTION EXERCISER. Classified as Exerciser, Powered (product code BXB), Class I - General Controls.

Submitted by Medical Technology and Innovations, Inc. (Grand Prairie, US). The FDA issued a Cleared decision on February 6, 1986 after a review of 100 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 Medical Technology and Innovations, Inc. devices

Submission Details

510(k) Number K854354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1985
Decision Date February 06, 1986
Days to Decision 100 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 115d · This submission: 100d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BXB Exerciser, 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.