Yamada Co., Ltd of Japan
Country not established
- Devices
- 1
What Yamada Co., Ltd of Japan makes
Yamada Co., Ltd manufactures a portable, battery-operated body warmer designed for patient comfort during medical procedures or transport. The device, known as SHAKE-N-WARM, is intended to maintain thermal regulation in individuals who may be at risk of hypothermia due to exposure or medical conditions.
The SHAKE-N-WARM body warmer is classified as a Class I medical device in the US and is listed under the FDA’s 510(k) pathway. The company is based in Japan but operates in the US market, adhering to regulatory requirements for low-risk devices.
Catalogue
Body Warmer (Shake-N-Warm) Ref K760441
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Yamada Co., Ltd of Japan have in the registry?
The registry currently lists 1 device for Yamada Co., Ltd of Japan. Devices recorded under merged duplicate company entries are counted once.
Which registries list Yamada Co., Ltd of Japan's devices?
Among its 1 most recently registered device, Yamada Co., Ltd of Japan has devices listed in FDA 510(k) (1 device).
What risk classes do Yamada Co., Ltd of Japan's devices fall under?
Among its 1 most recently registered device, the classes recorded for Yamada Co., Ltd of Japan's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Yamada Co., Ltd of Japan in the registry?
The most recently registered devices listed for Yamada Co., Ltd of Japan include BODY WARMER (SHAKE-N-WARM).