Cleared Traditional

RELAXU-1 (K950411) - FDA 510(k) Clearance

Class I Physical Medicine device.

K950411 · Kinsei Shiatsu, Inc. · Physical Medicine device
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Aug 1995
Decision
183d
Days
Class 1
Risk

K950411 is an FDA 510(k) clearance for the RELAXU-1. Classified as Massager, Therapeutic, Electric (product code ISA), Class I - General Controls.

Submitted by Kinsei Shiatsu, Inc. (Torrance, US). The FDA issued a Cleared decision on August 2, 1995 after a review of 183 days - an extended review 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: 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 Kinsei Shiatsu, Inc. devices

Submission Details

510(k) Number K950411 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1995
Decision Date August 02, 1995
Days to Decision 183 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
68d slower than avg
Panel avg: 115d · This submission: 183d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.

Regulatory Peers - ISA Massager, Therapeutic, Electric

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