Cleared Traditional

K952916 - SHIATSU MASTER MASSAGER CUSHION

K952916 is an FDA 510(k) clearance for SHIATSU MASTER MASSAGER CUSHION, manufactured by Kinsei Shiatsu, Inc.. The device is a Class 1 Physical Medicine device with product code IRO cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K952916 · Kinsei Shiatsu, Inc. · Physical Medicine device
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Aug 1995
Decision
63d
Days
Class 1
Risk

K952916 is an FDA 510(k) clearance for the SHIATSU MASTER MASSAGER CUSHION. Classified as Vibrator, Therapeutic (product code IRO), Class I - General Controls.

Submitted by Kinsei Shiatsu, Inc. (Torrance, US). The FDA issued a Cleared decision on August 28, 1995 after a review of 63 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 Kinsei Shiatsu, Inc. devices

FDA 510(k) Submission Details - K952916

510(k) Number K952916 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received June 26, 1995
Decision Date August 28, 1995
Days to Decision 63 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
52d faster than avg
Panel avg: 115d · This submission: 63d
Pathway characteristics
Predicate-based equivalence.

IRO Device Classification - Class 1, General Controls

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 22
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