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K Number
K213295
Device Name
C.C. LIFE 21
Manufacturer
21 Equipment S.R.L.
Date Cleared
2022-11-17

(412 days)

Product Code
PBX
Regulation Number
878.4400
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The C.C.Life 21 device with C-Life handle (RF) is indicated for the temporary relief of minor muscle aches and pain temporary relief of muscle spasm, and temporary improvement of local blood circulation.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter for a medical device called "C.C. Life 21". It does not contain information about acceptance criteria, device performance studies, or AI assistance. The letter confirms that the device is substantially equivalent to a legally marketed predicate device for the temporary relief of minor muscle aches and pain, muscle spasm, and temporary improvement of local blood circulation.

Therefore, I cannot provide the requested information based on the provided text. The document is solely a regulatory approval and does not detail the technical performance or validation studies of the device.

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.