Soken Co., Ltd.

Notification to the manufacturer is required when selling used medical devices.

In recent years, there have been an increasing number of cases of purchases from second-hand dealers on the Internet and auctions between individuals. Electromagnetic therapy device Soken Soken Relaxing start Electromagnetic therapy device Magspace and other OEM products are legally classified as "specified management medical devices", and regardless of whether they are new or used, they are sold (including awarding and lending). Appropriate management is required. In the case of second-hand sales, it is obligatory to notify the manufacturer (manufacturer / distributor) Soken Co., Ltd. and respect our instructions * .

* Article 170 of the Law Enforcement Regulations on Ensuring the Quality, Effectiveness, and Safety of Pharmaceuticals and Medical Devices, etc.

When purchasing electro-magnetic therapy device Magspace and other OEM products such as electro-magnetic therapy device Soken / Soken Relax, please check the "Notice to Manufacturer" to bidders and sellers at Internet auctions. In the case of second-hand products, the quality status of the equipment changes significantly depending on the usage management environment. It is absolutely not recommended as a manufacturer to use it without proper maintenance.

When purchasing a second-hand item, be sure to ask the sales company to check the following points.

<Confirmation points before purchase>
● Have you contacted the manufacturer / distributor (our company) of the medical device in advance to sell it as a second-hand product, and have you received instructions such as quality assurance and precautions for sales, or have you complied with the instructions?
● Are all accessories such as instruction manuals and precautions properly prepared?

<Related laws and regulations>
Pharmaceutical and Medical Device Law Enforcement Regulations (Notices Concerning Sales of Second-hand Goods, etc.)
Article 170 When a distributor of highly managed medical equipment, etc. sells, grants or rents used medical equipment to others, or intends to provide it through an electric line, it is a manufacturer and distributor of the medical equipment in advance. Must be notified. (Hereafter omitted)
2 When a distributor of highly managed medical equipment, etc. receives an instruction from the manufacturer / distributor of the medical equipment regarding ensuring the quality of the used medical equipment and other precautions regarding the sale, granting or lending of the medical equipment. Must comply with it.

Repair parts will be provided by the manufacturer for 10 years after manufacture.
The PL method (manufacturing liability) expiration date and the holding period of repair parts are both 10 years after manufacturing. Please note that it is difficult to specify the usage period at internet auctions.