Cleared Traditional

K914234 - SAUNETTE, PORTABLE STEAM CABIN

K914234 is an FDA 510(k) clearance for SAUNETTE, manufactured by Sauna Magic, Inc.. The device is a Class 2 Physical Medicine device with product code IMB cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K914234 · Sauna Magic, Inc. · Physical Medicine device
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Feb 1992
Decision
144d
Days
Class 2
Risk

K914234 is an FDA 510(k) clearance for the SAUNETTE, PORTABLE STEAM CABIN. Classified as Cabinet, Moist Steam (product code IMB), Class II - Special Controls.

Submitted by Sauna Magic, Inc. (Mississauga, Ontario, CA). The FDA issued a Cleared decision on February 11, 1992 after a review of 144 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5250 - 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 Sauna Magic, Inc. devices

FDA 510(k) Submission Details - K914234

510(k) Number K914234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1991
Decision Date February 11, 1992
Days to Decision 144 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
29d slower than avg
Panel avg: 115d · This submission: 144d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IMB Device Classification - Class 2, Special Controls

Product Code IMB Cabinet, Moist Steam
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5250
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.