21 Equipment S.R.L.
Italy(FDA 510(k) applicant) Last updated 22 Oct 2026
- Devices
- 2
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
C.C. Life 21 Ref K213295
C.C. Life 21 Ref K230459
What 21 Equipment S.R.L. makes
21 Equipment S.R.L. manufactures the C.C. LIFE 21, a cardiac compression device designed for external chest compressions during resuscitation efforts.
The company’s portfolio is regulated under FDA 510(k) clearance as Class II devices and is listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.
Frequently asked questions
What types of medical devices does 21 Equipment S.R.L. manufacture?
21 Equipment S.R.L. specializes in cardiac compression devices. Their primary product, the C.C. LIFE 21, is designed specifically for external chest compressions during resuscitation efforts, ensuring mechanical support during emergency cardiac care.
Where is 21 Equipment S.R.L. based, and how does this affect its regulatory oversight?
21 Equipment S.R.L. is based in the United States. Since the company’s devices fall under U.S. jurisdiction, their products are subject to FDA regulations, including the 510(k) clearance process for Class II devices, which ensures compliance with U.S. medical device standards.
Which regulatory registries list the devices manufactured by 21 Equipment S.R.L., and why?
The devices produced by 21 Equipment S.R.L., such as the C.C. LIFE 21, are listed in the FDA’s 510(k) registry. This registry tracks Class II devices that have undergone the 510(k) premarket notification process, demonstrating that the manufacturer has shown their device is substantially equivalent to a legally marketed predicate device.
How are the devices made by 21 Equipment S.R.L. classified under U.S. regulations?
The devices manufactured by 21 Equipment S.R.L., including the C.C. LIFE 21, are classified as Class II under U.S. FDA regulations. This classification requires a 510(k) clearance to ensure the device meets performance standards and safety requirements, as it poses moderate risk and typically involves special controls to mitigate potential hazards.
Information
- Country
- Italy