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Shenzhen Wells Optoelectronics Co., Ltd.

US

Last updated May 27, 2026

What Shenzhen Wells Optoelectronics Co., Ltd. makes

The company manufactures handheld electric massagers designed for muscle relaxation and pain relief, as well as phototherapy lamps emitting blue, red, and infrared light for skin and tissue treatment. It also produces multi-modality skin surface treatment systems combining various therapeutic modalities for targeted skin care applications.

All listed devices fall under Class I regulatory classification in the US and are registered in the FDA’s Unique Device Identifier (UDI) database. The company is based in Shenzhen, China, with its products authorised for commercial distribution in the United States.

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

Frequently asked questions

What types of medical devices does Shenzhen Wells Optoelectronics Co., Ltd. manufacture?

Shenzhen Wells Optoelectronics Co., Ltd. manufactures three primary categories of devices: hand-held electric massagers for muscle relaxation and pain relief, phototherapy lamps emitting blue, red, and infrared light for skin and tissue treatment, and multi-modality skin surface treatment systems that combine various therapeutic modalities for targeted skin care. These devices are designed to address specific wellness and therapeutic needs.

Where is Shenzhen Wells Optoelectronics Co., Ltd. based, and where are its devices authorised for use?

The company is based in Shenzhen, China. While its headquarters are in China, its devices are authorised for commercial distribution in the United States, where they undergo regulatory processes to ensure compliance with local standards.

Which regulatory registries list the devices manufactured by Shenzhen Wells Optoelectronics Co., Ltd.?

The devices produced by Shenzhen Wells Optoelectronics Co., Ltd. are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorised for use in the United States, ensuring transparency and traceability.

How are the devices from Shenzhen Wells Optoelectronics Co., Ltd. classified under US regulations?

All devices manufactured by Shenzhen Wells Optoelectronics Co., Ltd. fall under Class I regulatory classification in the United States. This classification is typically assigned to low-risk devices that pose minimal potential harm to users, such as hand-held massagers and phototherapy lamps, which require less stringent regulatory oversight compared to higher-risk categories.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
Address
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Website
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LinkedIn
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Facebook
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Email
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Phone
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PRRC Contact
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EUDAMED SRN
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FDA FEI Number
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DUNS Number
549645451

Catalogue (6)

DeviceModel / ReferenceRegistriesClassStatus
Shenzhen Wells Optoelectronics Co., Ltd. CD07S
FDA UDI
Class IActive
Shenzhen Wells Optoelectronics Co., Ltd. 939
FDA UDI
Class IActive
Shenzhen Wells Optoelectronics Co., Ltd. IR201
FDA UDI
Class IActive
Shenzhen Wells Optoelectronics Co., Ltd. 919AS
FDA UDI
Class IActive
Shenzhen Wells Optoelectronics Co., Ltd. DZ01
FDA UDI
Class IActive
Shenzhen Wells Optoelectronics Co., Ltd. DZ-01
FDA UDI
Class IActive

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