Cleared Traditional

K925666 - THERAPACER 3000

K925666 is the FDA 510(k) clearance for THERAPACER 3000 by Kvm Technologies, Inc.. It is a Class 1 Physical Medicine device (product code BXB) cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K925666 · Kvm Technologies, Inc. · Physical Medicine device
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Mar 1993
Decision
119d
Days
Class 1
Risk

K925666 is an FDA 510(k) clearance for the THERAPACER 3000. Classified as Exerciser, Powered (product code BXB), Class I - General Controls.

Submitted by Kvm Technologies, Inc. (Houston, US). The FDA issued a Cleared decision on March 9, 1993 after a review of 119 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 Kvm Technologies, Inc. devices

Submission Details

510(k) Number K925666 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 1992
Decision Date March 09, 1993
Days to Decision 119 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 115d · This submission: 119d
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.

Regulatory Peers - BXB Exerciser, Powered

All 31
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