Cleared Traditional

K912512 - TAICHI STICK MASSAGER

K912512 is an FDA 510(k) clearance for TAICHI STICK MASSAGER, manufactured by Focus International, Inc.. The device is a Class 1 Physical Medicine device with product code LYG cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K912512 · Focus International, Inc. · Physical Medicine device
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Sep 1991
Decision
92d
Days
Class 1
Risk

K912512 is an FDA 510(k) clearance for the TAICHI STICK MASSAGER. Classified as Massager, Therapeutic, Manual (product code LYG), Class I - General Controls.

Submitted by Focus International, Inc. (Rockville, US). The FDA issued a Cleared decision on September 6, 1991 after a review of 92 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 Focus International, Inc. devices

FDA 510(k) Submission Details - K912512

510(k) Number K912512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1991
Decision Date September 06, 1991
Days to Decision 92 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
23d faster than avg
Panel avg: 115d · This submission: 92d
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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