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 responsibility of a company handling medical devices.

The JFMDA is an industry association that formulates and manages voluntary standards for "Home Use Far-Infrared Ray Blood Circulation Promoting Garment." By joining the association that formulates these voluntary standards, we will further deepen our knowledge, including the management of the Pharmaceutical and Medical Device Act (PMD Act), and contribute to the sound development of the industry.

Furthermore, with an eye toward future global expansion of our business, we have also joined OMETA, which supports the overseas expansion of Japanese medical devices, as a supporting member. We will deepen our knowledge of responding to overseas medical device regulations and build a foundation to fulfill our responsibilities in the future.

TENTIAL has always prioritized protecting consumer health as a company handling medical devices. Through our membership in these two organizations, we will address medical device management with even greater sincerity and promote the social implementation of conditioning as an entity that can earn the trust of the industry.

* TENTIAL defines conditioning as "optimizing all factors related to physical condition for the improvement of life performance."

About the Japan Federation of Medical Devices Associations (JFMDA)

(Referenced from the Japan Federation of Medical Devices Associations HP "About JFMDA" https://www.jamdi.org/about/)

This federation was established in 1974 as the "Japan Medical Equipment Manufacturers Association (JAMEI)" with the aim of supplying safe medical equipment that supports the advancement of Japanese healthcare and the sound development of Japan's medical device manufacturing industry. Its activities are diverse, including industry surveys, collection of various information, standardization work for ISO and JIS, response to internationalization such as GHTF, and holding lectures and seminars. In 2009, to further establish and strengthen the federation's initiative and improve its information dissemination capabilities, it obtained legal personality. It made a new start as the "Japan Federation of Medical Devices Associations (Jamdi)" to lead the medical device industry in Japan with strong initiative and strive for its growth and development.

In recent years, as the presence of the medical device industry in the industrial world has grown year by year, the number of companies wishing to enter the medical device industry has increased due to the problem-solving support project by the Ministry of Economy, Trade and Industry, which began in 2010. The federation has also received many inquiries and consultations regarding new market entrants and is advancing various measures to respond to them.

The medical device industry is currently in an era of great change. Various challenges surround the medical device industry, including entry from other industries, regenerative medicine, medical safety, ICT, IoT, traceability utilizing barcodes and electronic tags, information sharing, human resource development, robotics, remote medicine, and globalization. The federation actively challenges these issues and contributes wholeheartedly to the growth of the medical device industry and medical device companies.

HP: https://www.jamdi.org/

About the Specified Non-Profit Corporation Overseas Medical Device Technology Cooperation Association (OMETA)

(Referenced from the Specified Non-Profit Corporation Overseas Medical Device Technology Cooperation Association HP "Business Activities" https://www.ometa.or.jp/profile)

This association was established on July 21, 1993, with the Special Corporation, Japan Pharmaceutical and Medical Devices Exporters Association, as its parent body. It received approval as a Specified Non-Profit Corporation from the Tokyo Metropolitan Government on March 24, 2000, and was incorporated as a non-profit organization on April 5 of the same year.

The association promotes the following activities regarding medical devices and other related equipment provided to the health and medical fields in developing countries through ODA (Official Development Assistance) implemented by the Japanese government:

Reactivate supplied equipment through follow-up and aftercare.

Support the stability and sound development of local medical institutions.

Support Japan's international cooperation projects and contribute to maintaining the credibility of Japanese-made medical devices in overseas markets.

HP: https://www.ometa.or.jp/

About TENTIAL Inc.

TENTIAL Inc., under the mission "Create a society that is proactive about health and unlock human potential," operates the conditioning brand "TENTIAL." CEO Yutaro Nakanishi, driven by the experience of his dream of becoming a professional soccer player being cut short by illness during high school, keenly felt the necessity of health and daily conditioning to maximize one's potential. Based on this experience, he founded TENTIAL Inc. with the aim of "implementing conditioning" in society.

The conditioning brand "TENTIAL" offers products and services that pursue functionality based on the knowledge of athletes and the latest technology and research. It promotes conditioning activities that support fatigue recovery and performance improvement by adjusting the mind and body in all aspects of daily life, 24 hours a day, 365 days a year. With the belief in unlocking individual condition and potential, TENTIAL Inc. is working on the social implementation of conditioning to realize a society that is proactive about health.

Company Profile

Company Name

TENTIAL Inc.

Established

February 2018

Capital

910 million yen (as of November 2025)

Representative

CEO Yutaro Nakanishi

Location

Gardengrace Shinagawa Gotenyama 5F, 6-7-29 Kita-Shinagawa, Shinagawa-ku, Tokyo 141-0001

Corporate Site

https://corp.tential.jp/

Business Activities

'TENTIAL' https://tential.jp/

Stock Exchange Listing

Tokyo Stock Exchange Growth

Various Social Media

X: https://x.com/TENTIAL_Inc

Instagram: https://www.instagram.com/tential/

YouTube: https://www.youtube.com/@tential5821

FACT BOX

  • Source: PR TIMES
  • Category: 企業動向