Cleared Traditional

QI GONG MASSAGER (K955250) - FDA 510(k) Clearance

Class I Physical Medicine device.

K955250 · East Health Development Group, Inc. · Physical Medicine device
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Feb 1996
Decision
87d
Days
Class 1
Risk

K955250 is an FDA 510(k) clearance for the QI GONG MASSAGER. Classified as Vibrator, Therapeutic (product code IRO), Class I - General Controls.

Submitted by East Health Development Group, Inc. (Tustin, US). The FDA issued a Cleared decision on February 8, 1996 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5975 - 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 East Health Development Group, Inc. devices

Submission Details

510(k) Number K955250 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received November 13, 1995
Decision Date February 08, 1996
Days to Decision 87 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
28d faster than avg
Panel avg: 115d · This submission: 87d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IRO Vibrator, Therapeutic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5975
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 - IRO Vibrator, Therapeutic

All 64
Devices cleared under the same product code (IRO) and FDA review panel - the closest regulatory comparables to K955250.
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ELECTRIC VIBRATOR
K761121 · Fred Sammons, Inc. · Dec 1976