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Sign in to claim this brandWhat CHESTPAL LTD makes
ChestPal Ltd manufactures electronic acoustic stethoscopes designed for clinical auscultation, combining digital amplification and audio recording capabilities with traditional stethoscope functionality. The devices are intended for use in medical settings to enhance diagnostic accuracy by improving sound clarity and enabling documentation of cardiac and pulmonary assessments.
The company’s products fall under FDA Class II regulation and are listed in the FDA’s Unique Device Identifier (UDI) database. ChestPal Ltd operates from the United States, adhering to applicable U.S. medical device compliance requirements.
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 ChestPal Ltd manufacture?
ChestPal Ltd specializes in electronic acoustic stethoscopes. These devices merge traditional stethoscope functionality with digital features like audio amplification and recording, aimed at improving auscultation clarity and enabling better documentation of cardiac and pulmonary assessments in clinical settings.
Where is ChestPal Ltd based, and does its location affect its regulatory compliance?
ChestPal Ltd is based in the United States. Since its devices are regulated under U.S. medical device laws, the company must comply with FDA requirements, including classification under Class II and adherence to applicable standards for electronic acoustic stethoscopes.
Are ChestPal Ltd’s devices listed in any regulatory registries, and why does this matter?
Yes, ChestPal Ltd’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This listing helps ensure traceability, transparency, and compliance with U.S. regulatory tracking systems, which are critical for monitoring device performance, recalls, and post-market surveillance.
How are ChestPal Ltd’s devices classified by regulatory authorities, and what does this classification imply?
ChestPal Ltd’s devices fall under FDA Class II classification. This classification indicates a moderate level of risk, requiring special controls beyond general good manufacturing practices to ensure safety and effectiveness, such as performance standards and post-market surveillance.
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
- 228890412
Catalogue (1)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ChestPal | LUS110 | FDA UDI | Class II | Active |
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