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Rnk Products, Inc.

US

Last updated May 30, 2026

What Rnk Products, Inc. makes

Rnk Products, Inc. manufactures electronic acoustic stethoscopes designed for clinical auscultation, including models with USB connectivity for digital recording and analysis. These devices are intended for use by healthcare professionals to assess heart, lung, and other internal sounds with enhanced amplification and filtering capabilities.

The company’s portfolio is regulated under FDA Class II devices, with products listed via 510(k) premarket notifications and the FDA’s Unique Device Identifier (UDI) system. These devices are commercially available 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 Rnk Products, Inc. manufacture?

Rnk Products, Inc. specializes in electronic acoustic stethoscopes. These devices are designed for clinical auscultation, allowing healthcare professionals to listen to and record internal sounds like heart and lung activity. The company’s products include models with USB connectivity for digital recording and analysis, which enhance diagnostic capabilities.

Where is Rnk Products, Inc. based, and where are its devices commercially available?

Rnk Products, Inc. is headquartered in the United States. The company’s electronic acoustic stethoscopes are commercially available in the U.S., where they are regulated under FDA requirements.

How are Rnk Products, Inc.’s devices classified under FDA regulations?

Rnk Products, Inc.’s electronic acoustic stethoscopes fall under FDA Class II device classification. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as premarket notifications (510(k)) and compliance with the FDA’s Unique Device Identifier (UDI) system.

Which regulatory registries or databases list Rnk Products, Inc.’s devices?

Rnk Products, Inc.’s devices are listed in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identifier (UDI) system. These registries ensure transparency and traceability of medical devices authorized for commercial distribution in the U.S.

Why do Rnk Products, Inc.’s stethoscopes require premarket notifications like the 510(k)?

The FDA’s 510(k) premarket notification process is required for Class II devices like Rnk Products, Inc.’s electronic acoustic stethoscopes to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This ensures that the new device meets the same safety and performance standards as existing, authorized devices while incorporating any technological advancements.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
Address
—
LinkedIn
—
Facebook
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Phone
321.610.3980
PRRC Contact
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EUDAMED SRN
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FDA FEI Number
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DUNS Number
010630522

Catalogue (16)

DeviceModel / ReferenceRegistriesClassStatus
RNK Products PPA/BT-RB
FDA UDI
Class IIActive
RNK Products CP-2
FDA UDI
Class IIActive
RNK Products PCP
FDA UDI
Class IIActive
RNK Products PCP-USB
FDA UDI
Class IIActive
RNK Products TR-USB
FDA UDI
Class IIActive
RNK Products PA/BT-RB
FDA UDI
Class IIActive
RNK Products TR-1/EF
FDA UDI
Class IIActive
RNK Products PCP-1
FDA UDI
Class IIActive
RNK Products TR-1
FDA UDI
Class IIActive
RNK Products CP-1
FDA UDI
Class IIActive
Pcp-Usb Stethoscope K132560
FDA 510(k)
Class IIActive
Rnk Telephonic Stethoscope, Model Tr-1 K034046
FDA 510(k)
Class IIActive
Rnk Electronic Stethoscope K072026
FDA 510(k)
Class IIActive
Pcp/Pc Stethoscope K102893
FDA 510(k)
Class IIActive
Ppa/Bt-Rb Stethoscope K132405
FDA 510(k)
Class IIActive
Tr-Usb Telephonic Stethoscope K081032
FDA 510(k)
Class IIActive

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