Gmail - request for review

Peter Heimlich <peter.heimlich@gmail.com>

request for review

Peter Heimlich <peter.heimlich@gmail.com> Mon, Jan 27, 2020 at 9:23 AM
To: Erica Williams <Erica.Williams@llr.sc.gov>
Cc: "Shuren, Jeff" <jeff.shuren@fda.hhs.gov>

Dear Ms. Williams,

1) Please find attached a pdf of my January 20, 2020 correspondence with Tomas Lopez, president of the Seville,
Spain company that markets the "Y-Strap" and whose website features video clips of Greenville chiropractor Joseph
Cipriano using the device.

Mr. Lopez's e-mail to me states:

(We) do not market (marketing) [sic] our product as a medical product. We never say they are intended to diagnose,
treat, cure, nor prevent any disease or health condition.

This appears to be reinforce one of the the concerns I brought to your attention in my January 14, 2020 letter, that Mr.
Cipriano may be improperly using the "Y-Strap" as a medical device to treat his patients. Therefore, would you please
append my letter to include that information and the other information in the pdf?

2) You may recall I copied Jeffrey Shuren, MD, JD, Director of the FDA's Center for Devices and Radiological Health
on my January 14, 2020 letter to you. That day Dr. Shuren e-mailed me that he had forwarded my letter to a FDA
department for review. I am copying him on this as a request to likewise forward the information in this e-mail.

Thank you for your continued attention and I look forward to your next communication.

Sincerely,

Peter M. Heimlich
Peachtree Corners, GA 30096 USA
ph: (208)474-7283
e-mail: peter.heimlich@gmail.com
website: http://medfraud.info
blog: http://the-sidebar.com
Twitter: https://twitter.com/medfraud_pmh
bio: http://tinyurl.com/ych7o7dr

cc: Jeffrey Shuren, MD, JD

encl: TLopez-PMH correspondence to date.pdf

[Quoted text hidden]

TLopez-PMH correspondence to date.pdf

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Gmail - Allegations Sent to the FDA - BY - CPT2000066

Peter Heimlich <peter.heimlich@gmail.com>

Allegations Sent to the FDA - BY - CPT2000066

1 message

CDRH Device Allegations <CDRHDeviceAllegations@fda.hhs.gov> Mon, Jan 27, 2020 at 3:36 PM

To: "peter.heimlich@gmail.com" <peter.heimlich@gmail.com>

Document Number: CPT2000066

Dear Mr. Heimlich:

This is in response to your correspondence received into the CDRH Office of Regulatory Programs, Division of
Regulatory Programs 3 (Market Intelligence), Allegation of Regulatory Misconduct Team on January 17, 2020.

Thank you for providing this information to the Food and Drug Administration (FDA). Information from regulated
industry and/or complainants is very helpful to us in identifying problems with marketed products and possible
violations of the laws that we enforce. We take such reports seriously, and we will evaluate this matter to determine
what follow-up action is appropriate. The type and extent of any follow-up is dependent upon the nature of the
problem reported, the potential impact on the public health, and the availability of our resources.

While FDA does not provide information on ongoing investigations, information can be obtained pursuant to a Freedom
of Information Act (FOIA) request, once an investigation is closed. Requests for this information can be submitted via
the agency online FOIA submission address at http://www.accessdata.fda.gov/scripts/foi/FOIRequest/index.cfm,

or in writing to the following address:

Food and Drug Administration

Freedom of Information Staff

ELEM 1029

12420 Parklawn Drive

Rockville, Maryland 20857

Gmail - Allegations Sent to the FDA - BY - CPT2000066

If you have any questions regarding this letter, please contact the Allegations of Regulatory Misconduct Team email
inbox at CDRHDeviceAllegations@fda.hhs.gov and reference the above document number.

Sincerely yours,

Allegation of Regulatory Misconduct Team

Division of Regulatory Programs 3 (Market Intelligence)

ORP | OPEQ | CDRH

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