Cleared Traditional

ANKLE REFLEX TREATMENT UNIT (ARTU) (K873658) - FDA 510(k) Clearance

Class I Physical Medicine device.

K873658 · Universal Gym Equipment, Inc. · Physical Medicine device
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Apr 1988
Decision
224d
Days
Class 1
Risk

K873658 is an FDA 510(k) clearance for the ANKLE REFLEX TREATMENT UNIT (ARTU). Classified as Exerciser, Powered (product code BXB), Class I - General Controls.

Submitted by Universal Gym Equipment, Inc. (New York, US). The FDA issued a Cleared decision on April 21, 1988 after a review of 224 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 Universal Gym Equipment, Inc. devices

Submission Details

510(k) Number K873658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1987
Decision Date April 21, 1988
Days to Decision 224 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
109d slower than avg
Panel avg: 115d · This submission: 224d
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.