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Sign in to claim this brandShenZhen Pentasmart Technology Co, .Ltd
US
Last updated May 25, 2026
What ShenZhen Pentasmart Technology Co, .Ltd makes
Shenzhen Pentasmart Technology Co., Ltd. manufactures handheld electric massagers and reusable acupressure applicators, including devices like eye massagers, cupping devices, and massage guns. Their portfolio also includes targeted massagers for the legs, lumbar region, abdomen, wrists, and scalp, designed for localized relief and relaxation.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States, adhering to regulatory requirements for medical devices in that jurisdiction.
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 Pentasmart Technology Co., Ltd. primarily manufacture?
ShenZhen Pentasmart Technology Co., Ltd. specializes in handheld electric massagers and reusable acupressure applicators. Their product line includes devices like eye massagers, cupping devices, massage guns, and targeted massagers for areas such as the legs, lumbar region, abdomen, wrists, and scalp. These devices are designed for localized relief and relaxation.
Where is ShenZhen Pentasmart Technology Co., Ltd. based, and how does this affect their devices?
The company is based in the United States, which means their devices must comply with U.S. regulatory requirements for medical devices. This includes adherence to FDA guidelines, classification under FDA’s risk-based categories, and potential listing in databases like the FDA’s Unique Device Identifier (UDI) system.
How are the devices manufactured by ShenZhen Pentasmart Technology Co., Ltd. classified by regulatory authorities?
The company’s devices fall under FDA’s Class I and Class II classifications. Class I devices generally pose minimal risk and may require less regulatory oversight, while Class II devices involve moderate risk and typically require special controls to ensure safety and effectiveness. Classification depends on factors like intended use and potential harm if misused.
Are the devices from ShenZhen Pentasmart Technology Co., Ltd. listed in any regulatory registries?
Yes, the company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their lifecycle, ensuring transparency and traceability for regulatory and market surveillance purposes.
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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- 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
- 551250083
Catalogue (22)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Eye massager | uLook-6511B | FDA UDI | Class II | Active |
| Cupping Device | uCute-2503B | FDA UDI | Class II | Active |
| Leg massager | uLeg-6560A | FDA UDI | Class I | Active |
| Massage Gun | uLax-6582A | FDA UDI | Class I | Active |
| Eye massager | uLook-6510A | FDA UDI | Class I | Active |
| Lumbar Traction Device | uLumb-6533B | FDA UDI | Class II | Active |
| Massage Gun | uLax-6580A | FDA UDI | Class I | Active |
| Abdomen Massager | uAngel-6532B | FDA UDI | Class II | Active |
| Wrist Massager | uWrist-6570A | FDA UDI | Class I | Active |
| Cupping Device | uCute-2500B | FDA UDI | Class II | Active |
| Wrist Massager | uWrist-6570B | FDA UDI | Class II | Active |
| Scalp Massager | uScalp-6505 | FDA UDI | Class I | Active |
| Eye massager | uLook -6512B | FDA UDI | Class II | Active |
| Knee massager | uLap-6550A | FDA UDI | Class I | Active |
| Cupping Device | uCute-2500A | FDA UDI | Class I | Active |
| Leg massager | uLeg-6560B | FDA UDI | Class II | Active |
| Knee massager | uLap-6550B | FDA UDI | Class II | Active |
| Head Massager | uIdea-6500B | FDA UDI | Class II | Active |
| Abdomen Massager | uAngel-6530B | FDA UDI | Class II | Active |
| Eye massager | uLook-6510B | FDA UDI | Class II | Active |
| Head Massager | uIdea-6501B | FDA UDI | Class II | Active |
| Knee massager | uLap-6553B | FDA UDI | Class II | Active |
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