Cleared Traditional

RELAXATION TANK (K812724) - FDA 510(k) Clearance

K812724 · Float-To-Relax, Inc. · Physical Medicine device
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Jan 1982
Decision
99d
Days
-
Risk

K812724 is an FDA 510(k) clearance for the RELAXATION TANK.

Submitted by Float-To-Relax, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 5, 1982 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel. 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 Float-To-Relax, Inc. devices

Submission Details

510(k) Number K812724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1981
Decision Date January 05, 1982
Days to Decision 99 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
16d faster than avg
Panel avg: 115d · This submission: 99d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -