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Sign in to claim this brandWhat K1MEDGLOBAL Co., Ltd. makes
K1MEDGLOBAL Co., Ltd. manufactures professional deep-tissue electromagnetic stimulation systems designed for non-invasive body contouring and muscle toning. Their devices include platforms like CORESCULPT and MAGSCULPT, which target subcutaneous fat and muscle tissue through controlled electromagnetic energy.
These products are classified as Class II medical devices under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from 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 K1MEDGLOBAL Co., Ltd. manufacture?
K1MEDGLOBAL Co., Ltd. specializes in professional deep-tissue electromagnetic stimulation systems. These devices are designed for non-invasive body contouring and muscle toning, targeting subcutaneous fat and muscle tissue through controlled electromagnetic energy. Examples include platforms like CORESCULPT and MAGSCULPT.
Where is K1MEDGLOBAL Co., Ltd. based?
K1MEDGLOBAL Co., Ltd. is based in the United States. This location is relevant for regulatory oversight and compliance with U.S. medical device regulations.
How are the devices manufactured by K1MEDGLOBAL Co., Ltd. classified under U.S. regulations?
The devices produced by K1MEDGLOBAL Co., Ltd., such as CORESCULPT and MAGSCULPT, are classified as Class II medical devices under FDA regulations. This classification typically indicates moderate risk and requires compliance with specific controls to ensure safety and effectiveness.
Are the devices from K1MEDGLOBAL Co., Ltd. listed in any regulatory databases?
Yes, the devices manufactured by K1MEDGLOBAL Co., Ltd. are listed in the FDA’s Unique Device Identifier (UDI) database. This database helps track and identify medical devices for regulatory, clinical, and commercial purposes, ensuring transparency and traceability.
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
- 987628867
Catalogue (2)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Coresculpt | MST-1002 | FDA UDI | Class II | Active |
| Magsculpt | MST-1001 | FDA UDI | Class II | Active |
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