Cleared Traditional

K862029 - SIEMENS RADIOTHERM 706, MICROWAVE THERAPY UNIT (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K862029 · Elmed, Inc. · Physical Medicine device
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Jul 1986
Decision
49d
Days
Class 2
Risk

K862029 is an FDA 510(k) clearance for the SIEMENS RADIOTHERM 706, MICROWAVE THERAPY UNIT. Classified as Diathermy, Microwave, For Use In Applying Therapeutic Deep Heat (product code IOA), Class II - Special Controls.

Submitted by Elmed, Inc. (Addison, US). The FDA issued a Cleared decision on July 16, 1986 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5275 - 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 Elmed, Inc. devices

Submission Details

510(k) Number K862029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1986
Decision Date July 16, 1986
Days to Decision 49 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
66d faster than avg
Panel avg: 115d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IOA Diathermy, Microwave, For Use In Applying Therapeutic Deep Heat
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5275
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.