Cleared Traditional

K922366 - SPINE LINE

K922366 is an FDA 510(k) clearance for SPINE LINE, manufactured by Dambrecine, Inc.. The device is a Class 1 Physical Medicine device with product code LYG cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K922366 · Dambrecine, Inc. · Physical Medicine device
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Jul 1992
Decision
54d
Days
Class 1
Risk

K922366 is an FDA 510(k) clearance for the SPINE LINE. Classified as Massager, Therapeutic, Manual (product code LYG), Class I - General Controls.

Submitted by Dambrecine, Inc. (Orlando, US). The FDA issued a Cleared decision on July 13, 1992 after a review of 54 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dambrecine, Inc. devices

FDA 510(k) Submission Details - K922366

510(k) Number K922366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1992
Decision Date July 13, 1992
Days to Decision 54 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
61d faster than avg
Panel avg: 115d · This submission: 54d
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

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