Inspections, Compliance, Enforcement, and Criminal Investigations
Electro-Therapeutic Devices, Inc. Company Response Letter
Electro-Therapeutic Devices Inc.
570 Hood Road, Suite 14
Markham, Ontario, Canada L3R 4G7
Tel: (905) 475-8344
Toll Free: 1-(877) 475-8344
Fax: (905) 475-5143
22nd March, 2006
Ms.Mary Ann Fitzgerald, Consumer safety Officer
Office of Compliance
Center for Devices and Radiological Health,
Food and Drug Administration
2094 Gaither Road, Rockville, MD 20850, USA
Re: Warning Letter – Accu-o-Matic SP Series/Addiquip.
Our company, Electro Therapeutic Devices Inc, 570 Hood Road, ste.14, Markham, Ont., Canada L3R 4G7, was issued a Warning letter by your department dated April 5, 2004, for the distribution of the Accu-O-Matic SP series device and Addiquip acupuncture needles.
We have since made compliance, which was accepted by your department, as per your letter dated December 10, 2004.
We would very much appreciate it, if our response can be posted on your web site.