Cleared Traditional

K950755 - FLEXMATE K500

K950755 is an FDA 510(k) clearance for FLEXMATE K500, manufactured by Breg, Inc.. The device is a Class 1 Physical Medicine device with product code BXB cleared through the Traditional 510(k) pathway after a 230-day FDA review.

K950755 · Breg, Inc. · Physical Medicine device
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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.

View all Breg, Inc. devices

FDA 510(k) Submission Details - K950755

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
115d slower than avg
Panel avg: 115d · This submission: 230d
Pathway characteristics
Predicate-based equivalence.

BXB Device Classification - Class 1, General Controls

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.

Regulatory Peers - BXB Exerciser, Powered

All 37
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