Cleared Traditional

K162240 - ProMedTek Model C1400 Shortwave Diather...

K162240 is an FDA 510(k) clearance for ProMedTek Model C1400 Shortwave Diather..., manufactured by Promedtek, Inc.. The device is a Class 2 Physical Medicine device with product code IMJ cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K162240 · Promedtek, Inc. · Physical Medicine device
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Nov 2016
Decision
100d
Days
Class 2
Risk

K162240 is an FDA 510(k) clearance for the ProMedTek Model C1400 Shortwave Diathermy Device. Classified as Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat (product code IMJ), Class II - Special Controls.

Submitted by Promedtek, Inc. (Scottsdale, US). The FDA issued a Cleared decision on November 17, 2016 after a review of 100 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 Promedtek, Inc. devices

FDA 510(k) Submission Details - K162240

510(k) Number K162240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2016
Decision Date November 17, 2016
Days to Decision 100 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 115d · This submission: 100d
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.

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All 20
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