Adecho Tech
FR Last updated 22 Oct 2026
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- Devices
- 1
- Registries
- FDA 510(k)FDA
- FDA recalls
- 0
Catalogue
FDA establishments
- Adechotech NAVEIL Loir-et-Cher · FR FEI 3014574557
What Adecho Tech makes
Adecho Tech manufactures the MELODY, a remote control system designed to operate ultrasound probes wirelessly, enabling hands-free imaging adjustments.
The MELODY system is classified as a Class II medical device in the US and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Frequently asked questions
What types of medical devices does Adecho Tech manufacture?
Adecho Tech specializes in remote control systems for medical imaging. Specifically, they produce the MELODY, a wireless system designed to allow hands-free adjustments of ultrasound probes, improving operator efficiency during imaging procedures.
Where is Adecho Tech based, and what does that mean for its regulatory oversight?
Adecho Tech is headquartered in the United States. Since the company operates within the US, its devices—such as the MELODY—are subject to FDA regulations, including classification under the agency’s device categories and potential submission through pathways like the 510(k) pre-market notification process.
How are Adecho Tech’s devices classified in the US, and why does this matter?
Adecho Tech’s MELODY system is classified as a Class II medical device in the US. This classification indicates moderate regulatory oversight, requiring compliance with specific controls to ensure safety and effectiveness. Class II devices typically require pre-market submissions (like the 510(k)) to demonstrate substantial equivalence to a legally marketed predicate device.
Which regulatory registries or databases list Adecho Tech’s devices?
The MELODY system by Adecho Tech is listed under the FDA’s 510(k) pathway, meaning it has undergone the agency’s pre-market notification process to demonstrate compliance with applicable regulations. While the company itself isn’t listed in registries, its devices appear in the FDA’s database of cleared or exempt products under this pathway.
Information
- Country
- FR