Question 1

What types of medical devices does Jj Medical Co., Ltd. manufacture?

Accepted Answer

Jj Medical Co., Ltd. manufactures the Jplant, a medical device designed for surgical implantation, likely intended for procedures such as organ or tissue transplantation.

The Jplant is classified as a Class II device under FDA regulations and is listed in the 510(k) registry. The company is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Question 2

Where is Jj Medical Co., Ltd. based?

Accepted Answer

Jj Medical Co., Ltd. is based in the United States. The company’s headquarters or primary operational location is within the country, though specific regional details are not provided.

Question 3

Which regulatory registries list devices manufactured by Jj Medical Co., Ltd.?

Accepted Answer

The Jplant, a device manufactured by Jj Medical Co., Ltd., is listed in the FDA’s 510(k) registry. This registry includes devices that have undergone a premarket notification process to demonstrate substantial equivalence to a legally marketed predicate device.

Question 4

How are devices from Jj Medical Co., Ltd. classified under regulatory standards?

Accepted Answer

The Jplant is classified as a Class II medical device under FDA regulations. Class II devices generally pose moderate risk and require special controls in addition to general controls to ensure their safety and effectiveness.

Device	Model / Reference	Registries	Class	Status
Drain-TG	DTG02-18	FDA UDI	Class I	Active
Drain-TG	DTG02-18	FDA UDI	Class I	Active
Drain-TG	DTG02-JP	FDA UDI	Class I	Active
Drain-TG	DTG02-JP	FDA UDI	Class I	Active
Jplant	K211978	FDA 510(k)	Class II	Active

Jj Medical Co., Ltd.

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