INTELECT SWD 100, MODEL 1600; SENIOR SOLUTIONS SHORTWAVE DIATHERMY, MODEL 1601— 510(k) K083433

Name: FDA 510(k) clearance K083433
Creator: U.S. Food and Drug Administration
Published: 2009-03-18

Substantially Equivalent

Chattanooga Group

FDA 510(k) clearance K083433 for INTELECT SWD 100, MODEL 1600; SENIOR SOLUTIONS SHORTWAVE DIATHERMY, MODEL 1601, Substantially Equivalent on 2009-03-18. Applicant: Chattanooga Group. Device class: 2.

Clearance details

Applicant: Chattanooga Group
Product code: Code IMJ
Device class: Class 2
Regulation: 21 CFR 890.5290
Advisory panel: Physical Medicine
Date received: 2008-11-20
Decision date: 2009-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hixson, TN, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K083433

K-number listed on FDA's recall record

Z-0121-2016 — Monode, Shortwave Accessory Model #: 02200002 Used in conjunction with the Intelect Shortwave Diathermy 100 and Intelect Shortwave Diathermy 400 units. For the clinical application of electromagnetic energy in the radio frequency of 27.12 megahertz to generate deep heat within body tissues.Class II·Terminated·DJO, LLC·20150821

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K083433.

Data sourced from openFDA. This site is unofficial and independent of the FDA.