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Sign in to claim this brandWhat TAIZHOU YUNKAI TECH CO LTD makes
Taizhou Yunkai Tech Co Ltd manufactures electric pad systems designed for localized-body heating, intended to provide targeted thermal therapy.
These devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database.
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 Taizhou Yunkai Tech Co Ltd manufacture?
Taizhou Yunkai Tech Co Ltd specializes in electric pad systems designed for localized-body heating. These devices are intended to deliver targeted thermal therapy to specific areas of the body, helping with conditions where heat application may be beneficial.
Where is Taizhou Yunkai Tech Co Ltd based?
The company is based in the United States, though the specific location within the country is not provided. This indicates its primary market or operational presence is within the US regulatory framework.
Which regulatory registries list Taizhou Yunkai Tech Co Ltd’s devices?
Taizhou Yunkai Tech Co Ltd’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices authorized for sale in the US, ensuring traceability and compliance.
How are Taizhou Yunkai Tech Co Ltd’s devices classified under FDA regulations?
Taizhou Yunkai Tech Co Ltd’s electric pad systems for localized-body heating fall under Class II classification by the FDA. This classification is typically assigned to devices that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- allstarmg.com
- —
- —
- [email protected]
- Phone
- 914 593-6670
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 699495401
Catalogue (7)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Calming Heat | CHCP-9 | FDA UDI | Class II | Unknown |
| Calming Heat | CHCC-6 | FDA UDI | Class II | Unknown |
| Calming Heat | CHCC-9 | FDA UDI | Class II | Unknown |
| Calming Heat | CHCC-9L | FDA UDI | Class II | Unknown |
| Calming Heat | CHCPCC-9 | FDA UDI | Class II | Unknown |
| Sharper Image | CH2-6 | FDA UDI | Class II | Active |
| Sharper Image | CH2-9 | FDA UDI | Class II | Active |
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