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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Kids Company Ltd Yugengaisha Kids, 12/3/08

   

hhsbluebirdDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
  Center for Devices and
Radiological Health
9200 Corporate Blvd
Rockville, MD 20850

 

DEC 3 2008


WARNING LETTER


VIA FEDERAL EXPRESS


Johdic Takano
KIDS Co., Ltd. YUGENGAISHA KIDS
2nd Floor, 3-3, 1-chome, Nishidai
Itami City Hyogo 664-0858
Japan


Re: Pyro-Energen II and the Pyro Nerve Stimulator


Dear Johdic Takano:


The Food and Drug Administration (FDA) has learned that your firm is marketing the
Pyro-Energen II and Pyro Nerve Stimulator Devices in the United States (U.S.) without
marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic
Act (the Act).


The FDA has reviewed your website, www.pyroenergen.com. for the Pyro-Energen II
and Pyro Nerve Stimulator products. The pyro-Energen II and the Pyro Nerve Stimulator
are devices within the meaning of Section 201 (h) of the Act, 21 U.S.C. 321(h), because
they are intended for use in the diagnosis of disease or other conditions or in the cure,
mitigation, treatment, or prevention of disease, or are intended to affect the structure or
function of the body.


The Pyro-Energen II and the Pyro Nerve Stimulator devices are adulterated under
section 501(f)(1)(B) of the Act 21 U.S.C. 351 (f)(1)(B), because you do not have
approved applications for premarket approval (PMA) in effect pursuant to section
SI5(a) of the Act, 21 U.S.C. 360e(a), or approved applications for an investigational
device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). The
devices are also misbranded under section 502(o) of the Act, 21 U.S.C. 352(o), because
you did not notify the agency of your intent to introduce the devices into commercial
distribution, as required by sections 510(k) of the Act, 21 U.S.C. 360(k).


The Pyro-Energen II device is also misbranded under section 502(a) of the Act, 21
U.S.C. 352(a), in that the labeling for this device, including your website and referenced
information, e.g., the Pyro-Energen Reference Book, contain statements which represent
or suggest that the Pyro-Energen device is effective to treat diseases that include
"AIDS/HIV, Allergies, Arthritis, Asthma, Cancer, Diabetes, Fibromyalgia, Hepatitis,
Herpes, Hypertension, Influenza, Insomnia, Kidney Diseases, Leprosy, Leukemia and
Meningitis." These representations or suggestions are false or misleading or otherwise
contrary to fact because this device has not been demonstrated to be effective for such
purposes.


The Pyro-Energen II device is also misbranded under section 502(f)(1) of the Act, 21
U.S.C. 352(f)(1), in that the labeling for the device fails to bear adequate directions for
use for the purposes for which it is intended, because adequate directions cannot be
written for such purposes, i.e., the treatment of specific disorders that include cancer or
viral disease.


The Pyro-Energen II and the Pyro Nerve Stimulator devices are also misbranded under
section 502 of the Act, 21 U.S.C. 352(0), in that the devices are manufactured, prepared,
propagated, compounded, or processed in an establishment not duly registered under 21
U.S.C 360; and were not included in a list required by 21 U.S.C. 360(j).


Given the serious nature of the violations of the Act, the Pyro-Energen II and the Pyro
Nerve Stimulator devices distributed by your firm are subject to refusal of admission
under section 801(a) of the Act, 21 U.S.C. 381(a), in that they appear to be adulterated
and misbranded. As a result, FDA may take steps to refuse these products, known as
"detention without physical examination," until these violations are corrected. In order to
remove the devices from detention, you should provide a written response to this
Warning Letter as described below and correct the violations described in this letter. We
will notify you if your response is adequate.


The FDA requests that Kids Co., Ltd. immediately cease the dissemination of all
promotional materials, including those on the Internet for the Pyro-Energen II and the
Pyro Nerve Stimulator devices the same as or similar to those described above. You
should take prompt action to correct the violations addressed in this letter.


Please submit a written response to this letter within IS working days from the date you
receive this letter, describing your intent to comply with this request, listing all
promotional materials for the Pyro-Energen II and the Pyro Nerve Stimulator devices the
same as or similar to those described above, and explaining your plan for discontinuing
the use of such materials. Please direct your response to Jennifer Medicus at the Food
and Drug Administration, Center for Devices and Radiological Health, Office of
Compliance, Division of Enforcement B, Radiology, Neurology, and Anesthesiology
Devices Branch (HFZ-340), 2094 Gaither Road, Rockville, MD 20850, facsimile at (240)
276-0129. We remind you that only written communications are considered official.


The violations discussed in this letter do not necessarily constitute an exhaustive list. It is
your responsibility to ensure that your promotional materials for the Pyro-Energen II and
the Pyro Nerve Stimulator devices comply with each applicable requirement of the Act
and FDA implementing regulations. 

 

Sincerely,

/S/

Timothy A. Ulatowski
Director
Office of Compliance
Center for Devices and
Radiological Health


cc: Bambi Dunn
1305 S. Lariat Dr.
Mustang, OK 73064
(USA Distributor)


cc: Yuichi Shimmi
Office Director
Office of Compliance and Standards
Pharmaceuticals and Medical Devices Agency
Shin-Kasumigaseki Building
3-3-2 Kasumigaseki, Chiyoda-ku
Tokyo 100-0013, Japan