Of the above, the part against Defendant B and C is reversed.

Defendant

B and C Co., Ltd. shall be punished by each fine of 500.

A. In the instant case, the Defendants asserted misunderstanding of facts as to medical appliances, which are the elements of the crime of violation of the Medical Devices Act and misapprehension of legal principles, the instant “Saiha Dodytec” (hereinafter the “instant organization”) is merely a sports aids used for the purpose of promoting physical effects in sports facilities (one kind of health clubs) operated by the Defendants, not a medical device used for medical purposes, such as diagnosis and treatment of diseases.

Nevertheless, the lower court found guilty of the facts charged in the instant case on the premise that the instant organization is a medical device. In so doing, the lower court erred by misapprehending the legal doctrine on medical device law.

B. The Defendants asserted erroneous determination of facts and misapprehension of legal principles with respect to the intent to commit the crime of violating the Medical Devices Act were used only for the purpose of sports assistance, and the instant apparatus was not used for the purpose of medical treatment. Therefore, the instant organization was not aware of the fact that it was a medical device.

Although the Defendants did not have any intention to violate the Medical Devices Act, the lower court which convicted the Defendants of the instant facts charged erred by misapprehending the facts concerning the intentional violation of the Medical Devices Act or by misapprehending the legal doctrine.

C. Defendant B’s assertion of misunderstanding of facts as to Defendant B’s advertisement advertisement and misapprehension of legal principles cannot be viewed as an advertisement under the Medical Devices Act.

Furthermore, the point of time when Defendant B puts up a medical device advertisement at issue is prior to the incorporation of Defendant C (hereinafter “Defendant Company”).

In full view of these circumstances, even if the conviction against the Defendants is recognized, the sentence of the lower court (the fine of KRW 500,000,000) is too unreasonable.

2. Determination

(a) Grounds for appeal

(a).

Article 2(1) of the Medical Devices Act provides that "medical appliances" shall be referred to as "medical appliances".