Cleared Traditional

K904242 - QI-GONG MACHINE THERAPEUTIC MASSAGER

K904242 is an FDA 510(k) clearance for QI-GONG MACHINE THERAPEUTIC MASSAGER, manufactured by China Healthways Institute. The device is a Class 1 Physical Medicine device with product code ISA cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K904242 · China Healthways Institute · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1990
Decision
24d
Days
Class 1
Risk

K904242 is an FDA 510(k) clearance for the QI-GONG MACHINE THERAPEUTIC MASSAGER. Classified as Massager, Therapeutic, Electric (product code ISA), Class I - General Controls.

Submitted by China Healthways Institute (San Clemente, US). The FDA issued a Cleared decision on October 11, 1990 after a review of 24 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 China Healthways Institute devices

FDA 510(k) Submission Details - K904242

510(k) Number K904242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1990
Decision Date October 11, 1990
Days to Decision 24 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 115d · This submission: 24d
Pathway characteristics
Predicate-based equivalence.

ISA Device Classification - Class 1, General Controls

Product Code ISA Massager, Therapeutic, Electric
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.