Cleared Traditional

K770086 - SANAR

K770086 is an FDA 510(k) clearance for SANAR, manufactured by Health Improvement Assoc.. The device is a Class 2 Physical Medicine device with product code IMB cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K770086 · Health Improvement Assoc. · Physical Medicine device
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Apr 1977
Decision
94d
Days
Class 2
Risk

K770086 is an FDA 510(k) clearance for the SANAR. Classified as Cabinet, Moist Steam (product code IMB), Class II - Special Controls.

Submitted by Health Improvement Assoc. (Mchenry, US). The FDA issued a Cleared decision on April 18, 1977 after a review of 94 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 Health Improvement Assoc. devices

FDA 510(k) Submission Details - K770086

510(k) Number K770086 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1977
Decision Date April 18, 1977
Days to Decision 94 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
22d faster than avg
Panel avg: 116d · This submission: 94d
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.