Question 1

What types of medical devices does Yamaha Motor Co., Ltd. manufacture?

Accepted Answer

Yamaha Motor Co., Ltd. specialises in electric-motor-driven wheelchair propulsion systems, commonly known as powered wheelchairs. These devices are designed to assist individuals with limited mobility by providing powered mobility solutions for both indoor and outdoor environments. The company’s focus is on mobility assistance, ensuring users can navigate various terrains with ease.

Question 2

Where is Yamaha Motor Co., Ltd. based, and how does this affect its regulatory presence?

Accepted Answer

Yamaha Motor Co., Ltd. operates with a US-based presence, which means its medical devices are subject to US regulatory requirements. Since the company’s products are authorised through pathways like the FDA’s 510(k) and UDI regulations, they are listed in the FDA’s regulatory databases, ensuring compliance with US medical device standards.

Question 3

Which regulatory registries list Yamaha Motor Co., Ltd.’s devices, and why are these important?

Accepted Answer

Yamaha Motor Co., Ltd.’s devices are listed in the FDA’s 510(k) and UDI registries. These registries are critical because they provide transparency on authorised medical devices, allowing healthcare providers, regulators, and patients to verify compliance with US safety and performance standards. Listing in these databases confirms that the devices meet the necessary regulatory criteria for market authorisation.

Question 4

How are Yamaha Motor Co., Ltd.’s devices classified under US regulations, and what does this classification imply?

Accepted Answer

Yamaha Motor Co., Ltd.’s devices fall under Class II classification in the US regulatory system. This classification indicates that while the devices pose moderate risk, they require special controls beyond general controls to ensure their safety and effectiveness. Class II devices typically undergo a premarket notification (510(k)) process to demonstrate substantial equivalence to a legally marketed predicate device, ensuring they meet established performance standards.

Question 5

Why are Yamaha Motor Co., Ltd.’s wheelchair propulsion systems authorised through the FDA’s 510(k) pathway?

Accepted Answer

The 510(k) pathway is used for Class II devices like Yamaha Motor Co., Ltd.’s wheelchair propulsion systems because it demonstrates that the new device is substantially equivalent to a legally marketed predicate device that was not required to undergo a premarket approval (PMA) application. This pathway ensures that the device meets the same safety and performance standards as existing authorised products, reducing regulatory burden while maintaining compliance with US medical device regulations.

Device	Model / Reference	Registries	Class	Status
Navione	X0EJ	FDA UDI	Class II	Active
Navione	X0EJ	FDA UDI	Class II	Active
Navigo	X0FC	FDA UDI	Class II	Active
Navione	X0EJ	FDA UDI	Class II	Active
Navione	X0EJ	FDA UDI	Class II	Active
Navigo	X0FC	FDA UDI	Class II	Active
Navione	X0EJ	FDA UDI	Class II	Active
Navione	X0EJ	FDA UDI	Class II	Active
Navione	X0EJ	FDA UDI	Class II	Active
Navione	X0EJ	FDA UDI	Class II	Active
Navigo	X0FD	FDA UDI	Class II	Active
Navigo	X0FD	FDA UDI	Class II	Active
Navione	X0EJ	FDA UDI	Class II	Active
Navione	X0EJ	FDA UDI	Class II	Active
Jwx-2	K140204	FDA 510(k)	Class II	Active
JWX-1 Plus (Navigo 16/Navigo 24)	K203806	FDA 510(k)	Class II	Active
Jwg-1	K252101	FDA 510(k)	Class II	Active

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