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 Exercise Equipment, Powered, Emg-Triggered
510(k) Number K062631
Device Name MYOMO E100
Applicant
Myomo, Inc.
529 Main St.
Suite 205
Boston,  MA  02129
Applicant Contact KATE ZEBROSE
Correspondent
Myomo, Inc.
529 Main St.
Suite 205
Boston,  MA  02129
Correspondent Contact KATE ZEBROSE
Regulation Number890.1375
Classification Product Code
OAL  
Date Received09/05/2006
Decision Date 04/12/2007
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
-
-