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 Massager, Powered Inflatable Tube
510(k) Number K221862
Device Name YY-A02-B Overlapped Compression Therapy
Applicant
Huizhou Xinyi Technology Co., Ltd.
Area (Bldg. 3), Changbu Village
Xinwei, Huiyang District
Huizhou,  CN 516200
Applicant Contact Jason Ye
Correspondent
Huizhou Xinyi Technology Co., Ltd.
Area (Bldg. 3), Changbu Village
Xinwei, Huiyang District
Huizhou,  CN 516200
Correspondent Contact Jason Ye
Regulation Number890.5650
Classification Product Code
IRP  
Date Received06/27/2022
Decision Date 12/08/2022
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
-
-