Question 1

What types of medical devices does Dongguan Dengrong Arts & Crafts Co., Ltd. manufacture?

Accepted Answer

The company produces battery-powered external manual massagers intended for home use. These devices are designed to provide muscle relief and relaxation through adjustable intensity settings for targeted pressure. They are portable and fall under the category of external manual massagers.

Question 2

Where is Dongguan Dengrong Arts & Crafts Co., Ltd. based?

Accepted Answer

The company is based in the United States. This location is relevant for regulatory compliance and distribution purposes, as it aligns with the FDA’s jurisdiction for device authorisation.

Question 3

Which regulatory registries list the devices manufactured by Dongguan Dengrong Arts & Crafts Co., Ltd.?

Accepted Answer

The company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices for regulatory and transparency purposes, ensuring traceability and compliance with U.S. requirements.

Question 4

How are the devices manufactured by Dongguan Dengrong Arts & Crafts Co., Ltd. classified?

Accepted Answer

The devices fall under Class I classification, which typically includes low-risk medical devices that pose minimal potential harm to users. This classification is determined by the FDA based on factors like intended use, duration of use, and risk level, allowing for streamlined regulatory oversight.

Device	Model / Reference	Registries	Class	Status
Artsun	ROSE QUARTZ MINI ROSE GOLD ROLL GUASHA SET	FDA UDI	Class I	Active
Artsun	CLEAR QUARTZ FLORAL ROLLER	FDA UDI	Class I	Active
Artsun	PINK ROSE GOLD ROLLER	FDA UDI	Class I	Active
Artsun	CLEAR QUARTZ SILVER ROLLER GUA SHA SET	FDA UDI	Class I	Active
Artsun	COLOURED TOURQISE RAINBOW STONE GUA SHA (RED)	FDA UDI	Class I	Active
Artsun	ROSE QUARTZ GUA SHA SET	FDA UDI	Class I	Active
Artsun	OPAL ROSE GOLD ROLLER GUA SHA SET	FDA UDI	Class I	Active
Artsun	JADE BODY GUA SHA	FDA UDI	Class I	Active
Artsun	GREEN GOLD ROLLER	FDA UDI	Class I	Active
Artsun	ROSE QUARTZ STD HEART GUA SHA	FDA UDI	Class I	Active
Artsun	JADE FLORAL ROSE GOLD ROLLER	FDA UDI	Class I	Active
Artsun	JADE GUASHA SET	FDA UDI	Class I	Active
Artsun	ROSE QUARTZ FLORAL ROSE GOLD ROLLER	FDA UDI	Class I	Active
Artsun	ROSE QUARTZ HEART SHAPE GUA SHA	FDA UDI	Class I	Active
Artsun	PINK GOLD CRYSTAL HANDLE	FDA UDI	Class I	Active
Artsun	ROSE QUARTZ MASSAGE WAND &GUA SHA SET	FDA UDI	Class I	Active
Artsun	ROSE QUARTZ CRYSTAL ROLLER GUA SHA SET	FDA UDI	Class I	Active
Artsun	PINK RG CRYSTAL HANDLE ROLLER	FDA UDI	Class I	Active
Artsun	JADE CRYSTAL GOLD ROLLER	FDA UDI	Class I	Active
Artsun	OPAL TRAVEL SET	FDA UDI	Class I	Active
Artsun	OPAL GUA SHA SET	FDA UDI	Class I	Active
Artsun	V SHAPE ROSE QUARTZ GOLDEN ROLLER	FDA UDI	Class I	Active
Artsun	JADE CRYSTAL GOLD ROLLER GUA SHA SET	FDA UDI	Class I	Active

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