Legal Information

Dear Clinician,

Thank you for your interest in AlternativeElectrodes.com. I am confident that you will like my electrodes and I’d like very much to have you as a customer.

In the recent past I have received many questions concerning FDA and the law. As I am not an expert in these matters, I have asked a respected FDA law firm to prepare a memorandum to answer some of these questions for you. As a courtesy to you, I am providing it to you free of charge.

In short, this memorandum explains FDA’s premarket review process and certain limitations the agency places on the promotion of medical devices. FDA does not regulate the practice of medicine.

In addition, with permission from Teresa Biber, CCC-SLP, I am making available a legal memorandum written on her behalf by a different attorney that also specializes in FDA law. This document contains additional information on how the FDA clears medical devices. Even though Teresa's document does not mention electrodes, electrodes and muscle stimulators are both Class II devices so the comments in her document also apply to electrodes. To access this document click on the second link below.

Other questions that I have received go to whether or not my electrodes are legally marketable. I assure you that they are and that I have taken every measure to ensure that I have fully complied with FDA law. It is for this reason that I will not, and cannot, promote them for any specific conditions or uses. It is up to you, the clinician, to use your professional judgment to use them as you know to be appropriate.

I hope this answers some of your questions. Be assured that my manufacturer has a 510(k) for my electrodes. If you want a copy of my FDA clearance letter you can print or download it directly from the FDA website. Simply go to www.FDA.gov and type K070807 into the search field. It is the first link that shows up.

Thank you for your time and I hope to have you as a customer.

Feel free to call or send me an email if you have any questions. I can be reached at 772-408-8085.

Please pass this letter and FDA memorandum on to your Risk Management Department, your department head, co-workers and professional friends both inside and outside of your company.

Sincerely,
Thomas H. Ireland
President, AlternativeElectrodes.com

CLICK HERE to open legal memorandum

CLICK HERE to open Teresa Biber's legal memorandum

CLICK HERE to read a press release on a lawsuit that AlternativeElectrodes has filed in Federal Court against Empi and VitalStim for anticompetitive business practices.

CLICK HERE to see resolution of lawsuit that was filed against Empi and VitalStim entities (January 2010).