TENTIAL Inc. (Location: Shinagawa-ku, Tokyo; CEO: Yutaro Nakanishi, hereinafter "TENTIAL"), which develops the conditioning brand "TENTIAL," aiming to realize a society that is proactive about health, is pleased to announce its membership as a regular member of the Japan Federation of Medical Devices Associations (hereinafter "JFMDA") and as a supporting member of the Specified Non-Profit Corporation Overseas Medical Device Technology Cooperation Association (hereinafter "OMETA"). TENTIAL's mission is to "Create a society that is proactive about health and unlock human potential," aiming to realize a society where everyone can challenge themselves and exhibit their potential in their own way. We believe that in addition to having abilities, it is important for people's potential to be in good condition. However, maintaining good condition is often perceived as something special. Therefore, TENTIAL will redesign all aspects of daily life from a conditioning perspective, making "maintaining good condition" a "daily norm" through products based on scientific evidence and R&D. Our recovery wear "BAKUNE" falls under the classification of general medical devices "Home Use Far-Infrared Ray Blood Circulation Promoting Garment (Class I)." This is a relatively new classification for medical devices, established in 2022, for garments that promote blood circulation by radiating far-infrared rays emitted from the body. In August 2024, our company obtained a Type II Marketing Approval for Medical Devices (Approval Number: 13B2X10608) and has established a system to handle everything from acquiring clinical evidence to quality management (QMS) and safety management (GVP) in-house. As a company handling medical devices that affect the human body, we believe it is our responsibility not only to obtain approvals and submit notifications but also to be responsible for the sound operation of the classification itself. Continuously maintaining such a system is, in our opinion, the respo