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 Sleeve, Limb, Compressible
510(k) Number K151377
Device Name ActiveCare+SFT;ActiveCare+SFT HomeCare, ActiveCare+DTx;ActiveCare+DTx HomeCare
Applicant
Medical Compression System (Dbn) , Ltd.
12 Ha'Llan St., P.O. Box 75
Or-Akiva,  IL 306000
Applicant Contact EYAL SANDACH
Correspondent
Medical Compression Systems (Dbn) , Ltd.
12 Ha'Ilan St., P.O. Box 75
Or-Akiva,  IL 3060000
Correspondent Contact ADELY LEVY
Regulation Number870.5800
Classification Product Code
JOW  
Date Received05/22/2015
Decision Date 07/16/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-