Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name stimulator, muscle, powered, for muscle conditioning
510(k) Number K222400
Device Name Coresculpt & Magsculpt
Applicant
K1MED Co., Ltd.
Rm.209, 1006, Woolim e-biz center II,
12, Digital-ro 33-gil, Guro-gu
Seoul,  KR
Applicant Contact Chang Ho Park
Correspondent
LK Consulting Group USA, Inc.
18881 Von Karman Ave. STE 160
Irvine,  CA  92612
Correspondent Contact Priscilla Chung
Regulation Number890.5850
Classification Product Code
NGX  
Date Received08/09/2022
Decision Date 02/27/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-