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U.S. Department of Health and Human Services

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Electro-Therapeutic Devices, Inc. FDA Response Letter

   

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
  2094 Corporate Blvd.
Rockville, MD 20850

 

December 10, 2004

FEDERAL EXPRESS   

Mr. K.C. Choong, Executive Officer

Electro-Therapeutic Devices, Inc.

570 Hood Road, Suite 14  

Markham, Ontario  

Canada   L3R 4G7

Dear Mr. Choong:

 

This is in response to your letter dated October 8, 2004, which we did not receive until November 16, wherein you provided some additional documentation that we discussed with you at our meeting of October 28, 2004, in Rockville, Maryland.

 

We have reviewed your information and have decided to close out the responses you have provided.  The adequacy of the changes to your procedures and documentation will be verified at the next routinely scheduled inspection at your facility.  Also, we are removing your ACCU-O-MATIC SP Series Transcutaneous Nerve Stimulator devices and ADDIQUIP Acupuncture Needles from import detention.  You may resume distribution of these products.

 

If you have any questions, you may contact me by telephone at 240-276-0120, or by email at maf@cdrh.fda.gov

Sincerely yours,

 

Mary Ann Fitzgerald

Consumer Safety Officer

Cardiovascular and Neurological

Devices Branch

Division of Enforcement B

Office of Compliance

Center for Devices and Radiological Health