Cleared Traditional

TAICHI STICK MASSAGER (K912512) - FDA 510(k) Clearance

Class I Physical Medicine device.

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

Submission Details

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.

Device Classification

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.