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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).


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The remedy for me is to love.
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