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 K201257
Device Name MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400)
Applicant
Arrive Systems, Inc.
113 Brakdale
New Ark,  DE  19711
Applicant Contact Aseem Gupta
Correspondent
Iuvo Consulting, LLC
P.O. Box 56436
Virginia Beach,  VA  23456
Correspondent Contact Rhonda Alexander
Regulation Number890.5850
Classification Product Code
NGX  
Subsequent Product Code
GZJ  
Date Received05/11/2020
Decision Date 04/06/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-