Cleared Traditional

K950755 - FLEXMATE K500 (FDA 510(k) Clearance)

Class I Physical Medicine device.

K950755 · Breg, Inc. · Physical Medicine device
Oct 1995
Decision
230d
Days
Class 1
Risk

K950755 is an FDA 510(k) clearance for the FLEXMATE K500. Classified as Exerciser, Powered (product code BXB), Class I - General Controls.

Submitted by Breg, Inc. (Vista, US). The FDA issued a Cleared decision on October 5, 1995 after a review of 230 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.

Submission Details

510(k) Number K950755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1995
Decision Date October 05, 1995
Days to Decision 230 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Regulatory Context
Review time vs. panel average
79d slower than avg
Panel avg: 151d · This submission: 230d
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.