고객 여러분

정말 기븐 소식을 전해 드립니다.

수지기가 2011. 12. 14일자로 호주 정부로 부터 1등급 의료기기 중,

치료기기(자극장치"Stimulator)로 승인, 등록 (ARTG 193081)이 되었습니다.

수지기 NVT 바이오 칩의 주요 기능은 다음과 같이 정의 되었습니다.

*인체에서 발생되는 개인의 고유한 주파수와 공명하고 보다 건강한 혈액세포를 생성하여

  인체의 생체장(Biofield)을 활성화 하고 강건하게 하기 위하여 사용하는 것을 목적으로 함.

*각각의 고유 주파수를 발생하는 다수의 특정한 튜닝 포크가 결합하여

  미묘한 진동 에너지를 발산하여 인체의 생체장(Biofield)과 상호 반응을 하게 된다.

*이 기기는 인체의 생체세포와 반응할 수 있도록 선정된 수많은 고유 주파수를 발생토록 하며

  일반적으로 피부층의 6인치 범위 내에 형성되는 BIOFIELD에 접속함으로서 그 효능을 발휘한다.

이는 수년간의 각종 임상시험 및 현장 체험과 더불어

약 4개월 이상에 걸친 호주 정부의 직접적이고 매우 정밀한 효능 검사 후에 주어진 결과 입니다.

잘 아시겠지만

호주정부는 모든 건강관련 기기, 식품, 약품 등의 승인 및 관리가  매우 철저하며 신중하답니다.

그동안 함께 성원해 주신 고객님 모든 분께 깊이 감사를 드립니다.

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Record Summary 193081 Shuzi Australia Pty Ltd - Stimulator,
Sponsor Shuzi Australia Pty Ltd
Therapeutic Type Medical Device
Product Category/ Class Included Class 1
ARTG Start date 14/12/2011
Postal Address PO Box 726, ALBANY CREEK, QLD, 4035
Australia
Billing Address PO Box 726, ALBANY CREEK, QLD, 4035
Australia
Conditions
The automatic conditions applicable to the inclusion of all kinds of medical devices in the Register are as specified in section 41FN of the Therapeutic
Goods Act 1989.
The standard conditions that are imposed under section 41FO of the Therapeutic Goods Act 1989 when kinds of medical devices are included in the
Register are as set out in the following paragraphs.
For a medical device included in the Register under Chapter 4 and imported into Australia, the Sponsor must ensure that information about the Sponsor is
provided in such a way as to allow the sponsor to be identified.
Each sponsor shall retain records of the distribution of all of the sponsor's medical devices included in the Register under Chapter 4. In the case of records
relating to a Class AIMD medical device, Class III medical device, or Class IIb medical device that is an implantable medical device, the distribution
records shall be retained for a minimum period of 10 years. In the case of records relating to any other device, the distribution records shall be retained for
a minimum period of 5 years.
The sponsor of a medical device included in the Register under Chapter 4 shall keep an up to date log of information of the kind specified in Regulation
5.8.
It is a condition of inclusion in the ARTG that the sponsor of a medical device that is an AIMD, Class III or implantable Class IIb provides three consecutive
annual reports to the Head of the Office of Devices, Blood and Tissues, Therapeutic Goods Administration following inclusion of the device in the ARTG.
(as specified in 5.8 of the regulations) Annual reports are due on 1 October each year. Reports should be for the period 1 July to 30 June. The first report
following the date of inclusion in the ARTG must be for a period of at least six months but no longer than 18 months. Subsequent reports are to be
provided on 1 October for a further 2 years. The annual report must include all complaints received by the manufacturer relating to problems with the use
of the device that have been received by them over the year.
Where a medical device included in the Register, contains a substance which is included in the Fourth Schedule to the Customs (Prohibited Imports)
Regulations or the Eighth Schedule to the Customs (Prohibited Exports) Regulations the Sponsor shall, at the time of importation or exportation of the
medical device, be in possession of a licence and a permission for importation or exportation of each consignment of the goods as required by those
regulations.
A sponsor shall ensure that a medical device within their control is stored and transported in accordance with the instructions and information provided by
the manufacturer.
Manufacturers
Name Address Certificate number(s)
Skytyan Inc 1433 Murchison Drive
Millbrae, CA, 94030
United States Of America
Products
1.Stimulator,
Product Type Single Device Product Status Current
Effective date 14/12/2011
GMDN 13762 Stimulator,
Functional description Not included on record
Intended purpose Intended for use to stimulate and strengthen the body's biofield by fine-tuning the body's own natural
frequency and providing healthier blood. The combination of multiple identical tuning forks that emit their
own frequency create a subtle vibrational energy, effective enough that it interacts with the body's biofield.
The device emits many unique frequencies chosen to be compatible with human cells, and is effective in
contact with the body's biofield, usually within 6 inches of the skin.
Variant information
Device Information
02 Anaesthetic and respiratory devices
11 Assistive products for persons with disability
04 Electro mechanical medical devices
Specific Conditions
No Specific Conditions included on Record
Poison information
Poison Not recorded
Record Summary
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