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
510(k) Number K221958
Device Name Flex-MI
Applicant
Emsi, Inc.
3504 Cragmont Sr., Suite 100
Tampa,  FL  33619
Applicant Contact Chad Sagnip
Correspondent
Msquared Associates, Inc.
127 W. 30th St.,
9th Floor
New York,  NY  10001
Correspondent Contact Cherita James
Regulation Number890.5850
Classification Product Code
IPF  
Subsequent Product Code
LIH  
Date Received07/05/2022
Decision Date 10/21/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-