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The remedy for me is to love.
Rabia
 

ONDAMED® and the FDA

Ondamed was celebrating in one of their news letters that they received registration with the FDA. However these are the facts:
  • Ondamed GmbH’s German establishment apparently is registered with FDA as a device manufacturer. See attached “Establishment Registration Database” summary from FDA’s website. This fact means that Ondamed GmbH filed a one-page Form FDA-2891 and possibly updates with FDA. This registration does not constitute FDA marketing clearance or approval for a medical device.
  • Ondamed, Inc.’s establishment (in New Windsor, New York) apparently is registered with FDA as an initial distributor of medical devices. See attached “Establishment Registration Database” summary from FDA’s website. This registration means that Ondamed, Inc. (or Ondamed GmbH on its behalf) filed a one-page Form FDA-2891 and possibly updates with FDA. Ondamed, Inc. appears to be owned by or affiliated with Ondamed GmbH. Again, this registration does not constitute FDA marketing clearance or approval for a medical device.
  • Ondamed GmbH has listed with FDA a device named “Ondamed.” The product is listed under the FDA classification name of “biofeedback device” (product code HCC; 21 C.F.R. § 882.5050; Class II). See attached “Device Listing Database” summary from FDA’s website. This listing means that Ondamed GmbH filed a one-page Form FDA-2892 and possibly updates with FDA. This listing does not constitute FDA marketing clearance or approval for a medical device.
  • A device known as the “Ondamed System” was placed on Import Alert by FDA as of April 29, 2003 for “lack of 510(k) approval,” i.e., lack of 510(k) marketing clearance. An Import Alert denotes that FDA will detain product without physical examination for a perceived violation and will refuse the product admission to the U.S. unless the violation is remedied. In Import Alert No. 89-08 (excerpt attached), the “Ondamed System” is referred to as a biofeedback device (product code 84HCC). The manufacturer is listed as Binder International GmbH & Co. or Binder GmbH (listing two addresses for Binder GmbH) in the Import Alert. The manufacturer is not listed as Ondamed GmbH or Ondamed, Inc. We assume that the Binder and Ondamed companies are related. Silvia Binder is the official correspondent for both Ondamed companies.
  • It is unclear what claims are made for any Ondamed (or Binder) biofeedback device, e.g., use in relaxation training, muscle re-education, other claims, etc., and whether the claims make the device 510(k)-exempt or not at this time. However, the “Ondamed System” was placed on Import Alert for lack of 510(k) clearance after biofeedback devices were 510(k)-exempted for certain claims. This fact possibly could indicate that claims were made for the “Ondamed System” that required 510(k) clearance and were not 510(k)-exempt at the time of inclusion in the Import Alert.
  • There are no marketing clearances or approvals for an Ondamed or Binder biofeedback device in FDA’s relevant website databases.
  • There is no information available on FDA’s website to indicate that Ondamed is in compliance or not with FDA’s other requirements for legal marketing of a biofeedback device in the U.S., i.e., labeling requirements (21 C.F.R. Part 801), adverse event reporting requirements (21 C.F.R. Part 803), and current good manufacturing practice requirements (21 C.F.R. Part 820).


delimiter
*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.

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The remedy for me is to love.
Rabia
 
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Do you want to know the real cause of your problems?
Do you want to take responsibility in your life admitting that you create it?
Do you want to live a life without fears and expectations?
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And finally do you want to share this knowledge with other people?
If your answer is yes, please contact us and we will show you how to reach these goals with the help of Inergetix-CoRe system and Kiran’s Dynamic Labile Equilibrium theory.", "/images/people/agnes-pal.jpg", "/hungary-distributor.html", "sr_contact.php?id=pal", "+36 23 334674", "en", false ); $af_salesrep["andrea@inergetix.com"] = array( "Ing. Andrea Gadducci", "All things, conditions and possibilities in our world are connected and interrelated. The Inergetix-CoRe System has an amazing capacity to reveal these connections and relationships in a very personal way and point them out in just a few minutes in a way that even the best human minds cannot do. This new, advanced technology, based on Quantum Physics and Global Scaling, has unlimited possibilities. I will be grateful to introduce you to the Inergetix-CoRe System, show you how to use it, customize it according to your needs, and assist you until you obtain the best results possible.", "/images/people/andrea.jpg", "/italy-distributor.html", "sr_contact.php?id=andrea", "+(39) 320 0688800", "en", false ); $af_salesrep["david@inergetix.com"] = array( "David Snoad", "CDS Enterprises ist in der Schweiz registriert und hat mehr als 20 Jahre Erfahrung in Informations- und energetischer Medizin. Die Firma wird von David Snoad mit Hilfe seiner Frau Carla geführt. David ist selber Naturheilpraktiker mit kantonaler Approbation im Kanton Appenzell in der Schweiz und kennt die Bedürfnisse und Wünsche seiner Kollegen und Kunden. Er ist überzeugt, dass die Zukunft der Medizin in der Informations-Medizin liegt. Philosophie der Firma und ihrer Mitarbeiter ist
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