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Sign in to claim this brandShenzhen Carewell Electronics., Ltd.
US
Last updated May 23, 2026
What Shenzhen Carewell Electronics., Ltd. makes
Shenzhen Carewell Electronics produces professional multichannel electrocardiograph devices, including AI-enabled ECG platforms under the Carewell brand. These systems are designed for clinical use to record and analyze multiple heart leads simultaneously, supporting diagnostic assessments in healthcare settings.
The company’s devices are classified as Class II under regulatory frameworks, with records submitted via FDA 510(k) and UDI listings. The portfolio is authorised for distribution in the United States, where the manufacturer is based.
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 Carewell Electronics., Ltd. manufacture?
Shenzhen Carewell Electronics., Ltd. specializes in professional multichannel electrocardiograph (ECG) devices. These systems are designed to simultaneously record multiple heart leads, enabling detailed cardiac diagnostics in clinical settings. The company also develops AI-enabled ECG platforms, which incorporate advanced technology to enhance analysis and interpretation of heart activity.
Where is Shenzhen Carewell Electronics., Ltd. based, and where are its devices authorised for use?
Shenzhen Carewell Electronics., Ltd. is based in the United States. Its devices are authorised for distribution in the US, where they undergo regulatory review to ensure compliance with local standards before entering the market.
Which regulatory registries or databases list Shenzhen Carewell Electronics., Ltd.’s devices?
Shenzhen Carewell Electronics., Ltd.’s devices are listed in the FDA’s 510(k) premarket notification registry and the FDA’s Unique Device Identifier (UDI) database. These registries track the regulatory submission and identification of medical devices authorised for use in the US.
How are Shenzhen Carewell Electronics., Ltd.’s devices classified under regulatory frameworks?
Shenzhen Carewell Electronics., Ltd.’s devices fall under Class II regulatory classification. This classification applies to devices that generally pose moderate risk and require special controls to ensure their safety and effectiveness, such as ECG systems that require validation of performance and labeling requirements.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (8)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Carewell | ECG-1112D | FDA UDI | Class II | Active |
| Carewell | ECG-1103G(I) | FDA UDI | Class II | Active |
| Carewell | ECG-1101G(I) | FDA UDI | Class II | Active |
| Carewell | ECG-1103LW(I) | FDA UDI | Class II | Active |
| Carewell | ECG-1106L | FDA UDI | Class II | Active |
| Carewell | ECG-1112 | FDA UDI | Class II | Active |
| AI-ECG Tracker | K200036 | EUDAMEDFDA 510(k) | Class II | Active |
| AI-ECG Platform | K180432 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Shenzhen Carewell Electronics Co., Ltd. Shenzhen Guangdong · CN FEI 3010089768