Cleared Traditional

ProMedTek Model C1400 Shortwave Diathermy Device

K162240 · Promedtek, Inc. · Physical Medicine

Nov 2016

Decision

100d

Days

Class 2

Risk

About This 510(k) Submission

K162240 is an FDA 510(k) clearance for the ProMedTek Model C1400 Shortwave Diathermy Device, a Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat (Class II — Special Controls, product code IMJ), submitted by Promedtek, Inc. (Scottsdale, US). The FDA issued a Cleared decision on November 17, 2016, 100 days after receiving the submission on August 9, 2016. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5290.

Submission Details

510(k) Number	K162240 FDA.gov
FDA Decision	Cleared 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

Device Classification

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