LogoFDA 510(k) Search
K Number
K222400
Device Name
Coresculpt & Magsculpt
Manufacturer
K1MED Co., Ltd.
Date Cleared
2024-02-27

(567 days)

Product Code
NGX
Regulation Number
890.5850
Type
Traditional
Panel
PM
Reference & Predicate Devices
N/A
Predicate For
K231500
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).