Question 1

What types of medical devices does Zhejiang Lumeng Health & Technology Co., Ltd. manufacture?

Accepted Answer

Zhejiang Lumeng Health & Technology Co., Ltd. specializes in electric pad localized-body heating systems. These devices are designed to provide temporary relief for muscle and joint discomfort. The company markets its products under well-known brands like SHARPER IMAGE and All Star.

Question 2

Where is Zhejiang Lumeng Health & Technology Co., Ltd. based?

Accepted Answer

The company is based in the United States. While the name suggests a Chinese origin, the manufacturing operations and regulatory presence are established within the US market.

Question 3

How are the devices manufactured by Zhejiang Lumeng Health & Technology Co., Ltd. classified under FDA regulations?

Accepted Answer

The devices produced by Zhejiang Lumeng Health & Technology Co., Ltd., specifically their electric pad localized-body heating systems, fall under Class II classification according to FDA regulations. This classification typically applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness.

Question 4

Are the devices listed in any regulatory registries?

Accepted Answer

Yes, the devices manufactured by Zhejiang Lumeng Health & Technology Co., Ltd. are included in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices to ensure transparency and traceability in the healthcare system.

Device	Model / Reference	Registries	Class	Status
Sharper Image	31579	FDA UDI	Class II	Active
Sharper Image	CWT12006	FDA UDI	Class II	Active
Sharper Image	723070-474	FDA UDI	Class II	Active
All star	771644	FDA UDI	Class II	Active
Sharper Image	CWT05112	FDA UDI	Class II	Active
All star	31583	FDA UDI	Class II	Active
Sharper Image	723054-507	FDA UDI	Class II	Active
Sharper Image	CH2-9L	FDA UDI	Class II	Active
Sharper Image	CHJ-9	FDA UDI	Class II	Active
Sharper Image	CH2-6	FDA UDI	Class II	Active
Sharper Image	31456	FDA UDI	Class II	Active
All star	31690	FDA UDI	Class II	Active
All star	CWT18004	FDA UDI	Class II	Active
All star	31633	FDA UDI	Class II	Active
All star	31695	FDA UDI	Class II	Active
Calming Heat Sauna Wrap	CHSW-3	FDA UDI	Class II	Active
Sharper Image	CHNW-3	FDA UDI	Class II	Active
Sharper Image	CHC-3	FDA UDI	Class II	Active
Sharper Image	CH2-9	FDA UDI	Class II	Active
Sharper Image	CWT03106	FDA UDI	Class II	Active
Sharper Image	31581	FDA UDI	Class II	Active
Sharper Image	CHKW-5	FDA UDI	Class II	Active
Sharper Image	723070-507	FDA UDI	Class II	Active
Sharper Image	723054-474	FDA UDI	Class II	Active
All star	CWT17003	FDA UDI	Class II	Active
Sharper Image	31580	FDA UDI	Class II	Active
Sharper Image	31584	FDA UDI	Class II	Active
Sharper Image	CWT11006	FDA UDI	Class II	Active
All star	31582	FDA UDI	Class II	Active

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