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 Pump, Breast, Powered
510(k) Number K260864
Device Name Mother's Nature W1 Warming Wearable Breast Pump
Applicant
Shenzhen TPH Technology Co., Ltd.
Rm. 203, 2nd Floor, 29th Bldg., Lianchuang Technology Park,
Shenzhen,  CN 518000
Applicant Contact Dale WANG
Correspondent
Shenzhen TPH Technology Co., Ltd.
Rm. 203, 2nd Floor, 29th Bldg., Lianchuang Technology Park,
Shenzhen,  CN 518000
Correspondent Contact Dale WANG
Regulation Number884.5160
Classification Product Code
HGX  
Date Received03/17/2026
Decision Date 06/09/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-