Myovision reply

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Below is Myovision President Macarian's explanation of the November 2007 FDA letter. Apparently that issue was resolved quickly, but the letter continues to circulate. Activator Methods endorses the Myovision, hence my inquiryRon Johansen DC, Portland ,Activator Clinical Instructor.-

Dear Doctors:

RE: FDA Warning Letter dated November 28, 2007

To be honest, if whoever started this “rumor” put the same energy into their own product as they do attacking MyoVision, we may actually be competitors. With the release of the most significant advancement in instrumentation technology in 20 years, the new MyoVision 3G Wirefree™ System, MyoVision is now the clearest choice in instrumentation.

Fortunately for us, there is no such thing as bad publicity, and their attempt to redirect you to an alleged FDA issue (resolved months ago) has instead driven over a 1000 doctors to our website to download the new e-brochure (click on the “Stealth Bomber” photo at www.myovision.com).

Rest assured: This FDA letter was dated November of 2007, almost 5 months ago. It is “old news” and was resolved immediately.

But please do NOT rely upon my word or that of the competition (obviously) but go directly to the FDA’s website by following the link below and you will see that MyoVision is in full compliance.

If we had to actually “cease marketing”, you would not find us on FDA’s website under “device listing”. No ifs, ands or buts.

Copy and paste this link into your browser if you cannot CTRL-CLICK on it:

a. Go to www.fda.gov/cdrh/databases.html

b. On the far left, halfway down the page

click on “REGISTRATION & LISTING”

c. Simply type “PRECISION BIOM” in the 3RD

Field down: “OWNER/OPERATOR NAME” (there is no need to use the whole company

name, as most don’t fit. My company, Precision Biometrics, Inc. is the

manufacturer of the MyoVision).

d. Click SEARCH at the bottom left.

e. You will see “MYOVISION” 8000 appear

proving that MyoVision is cleared by the

FDA, is a CLASS II device, and is being sold

legally in the United States.

If we did NOT resolve the matter, you would not find us listed at all.

I would like to thank the competition for the free marketing, but I wish that we as a profession would stop the infighting, and allow the experts at MyoVision to continue to develop the very instrumentation which won the Landmark Superior Court Decision in Florida, and protects your right to practice.

I would like to apologize for them, as this “non-issue”, took away your time from patient care, and my time from fighting the legal battles which have been so crucial to our success as a profession.

If you have any questions, you can email me directly at david@....

Sincerely

Marcarian

President

Please cc: myovision on all business related matters. To reach directly call 206-448-3464.

For technical support issues, contact PBI at 800-969-6961 or email support@....

Marcarian, MA

President

PBI/MyoVision Personal Direct: 206-448-3558

Seattle Office 206-448-3464 fax: 206-770-6176

2801 1st Avenue, Unit 1212

Seattle, WA 98121

Main Office:

981-A Industrial Road

San , CA 94070

800-969-6961 /650-508-2600

www.myovision.com

Sales Questions: Silacci: info@...

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From: drjohansen@... [mailto:drjohansen@...] Sent: Saturday, March 15, 2008 10:12 AMdavid@...Cc: jjhamco@...Subject: source of FDA letter

, the source of the warning letter link I sent to Arlan Fuhr was Warren Jahn,via the chat list which has about 200 Docs on it. Do I have your permission to send your reply to Judi Fuhr to this group so this sniping can be cleared up? Of course I would only send your reply and not any correspondence with Activator. R Johansen D.C.,DABCO

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