If you go to the FDA website FDA.gov and enter ONDAMED into the search field you get the following result:
Import ALERT for Ondamed system by FDA
IA #89-08, 8/13/01, "IMPORT ALERT #89-08, "DWPE OF DEVICES W/O APPROVED PMA'S OR IDE'S AND OTHER DEVICES NOT EQUIVALENT OR NO 510K" ATTACHMENT REVISED 2/8/08 NOTE: This revision is being issued to revise the alert into the current format and terminology. Changes are bracketed by asterisks (***). TYPE OF ALERT: *** Detention Without Physical Examination (DWPE) *** NOTE: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public. PRODUCT: *** Medical devices (see attachment) *** PRODUCT CODE: *** See attachment *** PROBLEM: Devices are being distributed without a 510(k) Binder International Ondamed System Regulation Lack of 510(k) GmbH & Co. (Biofeedback Device) Approval Otto Hahn Strasse 19 84HCC Herrenberg-Kuppingen 04/29/03 Germany FEI #3003752197 Binder GmbH P.O. Box 102 Tuttlingen Germany FEI #3003765734 Binder GmbH Kurzeller Str. 18 Schwanau,
After Ondamed tried to shut down the Inergetix website because we were propagating information that was obviously contradicting their general misinformation of their customers or possible customers they now tried another dirty trick from their “holistic” health cabinet.
Bruce Swartz – Atlanta, GA
They hired the services of this very charming gentleman:
He lives in Brookhaven Fields
2302 Briarwood Hills. Dr. NE
Atlanta, Georgia 30319
678-392-3218 | bruce@growonlinenow.com
Some of the websites of this prolific talker:
http://www.energymedicineeducation.net
http://www.qalias.com/view_profile/Bruce/I/Swartz/101/0/
http://www.linkedin.com/in/growonlinenow
http://www.fastpitchonline.com/BruceSwartz/ - from this site : “Fast Pitch! is an online business network that helps you make connections and market your business to other professionals.”... and teach you how to put others down
http://www.dr-kessler.com/dr_kesslers_e-book_on_ondamed.php
www.GrowOnlineNow.com
http://www.teleconferenceinfo.net/ - One of his websites which is dedicated to ONDAMED
And he devised a great new strategy to hurt Inergetix... They are now paying google ads that for search terms like:
INERGETIX or KIRAN SCHMIDT
It will display a paid ad that links to a Seattle Times propaganda (paid by the pharma industry) to discredit energy medicine. This series of articles is not coined for Inergetix but for EPFX/QXCI/SCIO and its founder Bill Nelson.
It is almost unbelievable, giving the fact that Ondamed has an Import Ban, is making the following statement on his website that is financed by Ondamed:
http://www.energymedicineeducation.net – The term “Energy Medicine” calls out for human interaction, not automatic, automated, and/or random device processes.
Some manufacturers of energy medicine devices promise unreasonable and unethical diagnosis and healing approaches with their devices. With their disinformation, lies and deceit, these manufacturers and others are responsible for creating confusion along with a shroud of distrust in the field of energy medicine. Disinformation and misinformation is affecting the medical field globally due to the relatively smallness of the alternative medicine market in relation with the many different sellers of energy medicine devices. Several of these devices offered have never undergone safety inspections, medical device certifications or market clearance in their respective markets and this can be extremely dangerous. [Ref Seattle Times Ban] Besides the illegal labeling, distribution, and use of such devices, patients and users are at a great safety and health risk.
He is even soliciting for money there on the Contact page for this DIRTY campaign.
It is clear that ONDAMED is reaping what it is sowing... Unlike Inergetix it has now an Import ban and Ondamed devices can be confiscated “without inspection”.
*To avoid misinterpretation of words such as energy-medicine, informational-medicine, treat, cure, diagnose, illness, disease, remedy and spiritual healing please study our Vision & Mission and Disclaimer pages carefully. CoRe System users in the USA are required to read and accept these interpretations.
© 2007-2008, Inergetix, Inc. All Rights Reserved
|