Cleared Traditional

K930613 - HOOKING SYSTEM

K930613 is an FDA 510(k) clearance for HOOKING SYSTEM, manufactured by Alain Machtelinckx. The device is a Class 1 Physical Medicine device with product code LYG cleared through the Traditional 510(k) pathway after a 522-day FDA review.

K930613 · Alain Machtelinckx · Physical Medicine device
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Jul 1994
Decision
522d
Days
Class 1
Risk

K930613 is an FDA 510(k) clearance for the HOOKING SYSTEM. Classified as Massager, Therapeutic, Manual (product code LYG), Class I - General Controls.

Submitted by Alain Machtelinckx (West Linn, US). The FDA issued a Cleared decision on July 12, 1994 after a review of 522 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5660 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

View all Alain Machtelinckx devices

FDA 510(k) Submission Details - K930613

510(k) Number K930613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1993
Decision Date July 12, 1994
Days to Decision 522 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
407d slower than avg
Panel avg: 115d · This submission: 522d
Pathway characteristics
Predicate-based equivalence.

LYG Device Classification - Class 1, General Controls

Product Code LYG Massager, Therapeutic, Manual
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5660
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 - LYG Massager, Therapeutic, Manual

Devices cleared under the same product code (LYG) and FDA review panel - the closest regulatory comparables to K930613.
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