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

Device Classification Under Section 513(f)(2)(De Novo)
  • 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 wearable fall injury prevention device
De Novo Number DEN240021
Device Name Tango® Belt (Model SAS-001-01 (XS); Model SAS-001-02 (S); Model SAS-001-03 (M); Model SAS-001-04 (L); Model SAS-001-05 (XL))
Requester
active protective technologies, inc.
580 virginia drive, suite 230
fort washington,  PA  19034
Contact wamis singhatat
Regulation Number890.3780
Classification Product Code
SEC  
Date Received05/16/2024
Decision Date 04/09/2025
Decision granted (DENG)
Classification Advisory Committee Physical Medicine
Review Advisory Committee Physical Medicine
Classification Order Classification Order
Type Direct
Predetermined Change
Control Plan Authorized		 No
-
-