Cleared Traditional

K952043 - BACK MASSAGER

K952043 is an FDA 510(k) clearance for BACK MASSAGER, manufactured by Eight Corners, Inc.. The device is a Class 1 Physical Medicine device with product code LYG cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K952043 · Eight Corners, Inc. · Physical Medicine device
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Sep 1995
Decision
123d
Days
Class 1
Risk

K952043 is an FDA 510(k) clearance for the BACK MASSAGER. Classified as Massager, Therapeutic, Manual (product code LYG), Class I - General Controls.

Submitted by Eight Corners, Inc. (East Brunswick, US). The FDA issued a Cleared decision on September 1, 1995 after a review of 123 days - within the typical 510(k) review window.

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: 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 Eight Corners, Inc. devices

FDA 510(k) Submission Details - K952043

510(k) Number K952043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1995
Decision Date September 01, 1995
Days to Decision 123 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
8d slower than avg
Panel avg: 115d · This submission: 123d
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 K952043.
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