Cleared Traditional

LATERAL FLEXION MACHINE (K940455) - FDA 510(k) Clearance

Class I Physical Medicine device.

K940455 · Rehab, Inc. · Physical Medicine device
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Jan 1995
Decision
345d
Days
Class 1
Risk

K940455 is an FDA 510(k) clearance for the LATERAL FLEXION MACHINE. Classified as Exerciser, Powered (product code BXB), Class I - General Controls.

Submitted by Rehab, Inc. (Knoxville, US). The FDA issued a Cleared decision on January 12, 1995 after a review of 345 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Rehab, Inc. devices

Submission Details

510(k) Number K940455 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received February 01, 1994
Decision Date January 12, 1995
Days to Decision 345 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
230d slower than avg
Panel avg: 115d · This submission: 345d
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.