Cleared Traditional

K852166 - THERMO SHORTWAVE DIATHERMY

K852166 is an FDA 510(k) clearance for THERMO SHORTWAVE DIATHERMY, manufactured by Zimmer Elektromedizin GmbH. The device is a Class 2 Physical Medicine device with product code IMJ cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K852166 · Zimmer Elektromedizin GmbH · Physical Medicine device
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Sep 1985
Decision
133d
Days
Class 2
Risk

K852166 is an FDA 510(k) clearance for the THERMO SHORTWAVE DIATHERMY. Classified as Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat (product code IMJ), Class II - Special Controls.

Submitted by Zimmer Elektromedizin GmbH (7910 Neu-Ulm, Germany, DE). The FDA issued a Cleared decision on September 30, 1985 after a review of 133 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5290 - 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 Zimmer Elektromedizin GmbH devices

FDA 510(k) Submission Details - K852166

510(k) Number K852166 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received May 20, 1985
Decision Date September 30, 1985
Days to Decision 133 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
18d slower than avg
Panel avg: 115d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IMJ Device Classification - Class 2, Special Controls

Product Code IMJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5290
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.

Regulatory Peers - IMJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat

All 29
Devices cleared under the same product code (IMJ) and FDA review panel - the closest regulatory comparables to K852166.
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K781455 · Elmed, Inc. · Dec 1978
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K780755 · Birtcher Corp. · May 1978