Cleared Traditional

E-Z FLEX (K953456) - FDA 510(k) Clearance

Class I Physical Medicine device.

K953456 · Fluid Motion Biotechnologies, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
191d
Days
Class 1
Risk

K953456 is an FDA 510(k) clearance for the E-Z FLEX. Classified as Exerciser, Powered (product code BXB), Class I - General Controls.

Submitted by Fluid Motion Biotechnologies, Inc. (Great Neck, US). The FDA issued a Cleared decision on January 26, 1996 after a review of 191 days - an extended review cycle.

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 Fluid Motion Biotechnologies, Inc. devices

Submission Details

510(k) Number K953456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1995
Decision Date January 26, 1996
Days to Decision 191 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
76d slower than avg
Panel avg: 115d · This submission: 191d
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.