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 Wheelchair, Powered
510(k) Number K251565
Device Name Wheelchair (N817)
Applicant
Zhejiang Topwe Tools Manufacturing Co.,Ltd
#3 Bldg., 133 Yingui N. Rd., Xicheng St.
Yongkang,  CN 321300
Applicant Contact Liang Wang
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, 1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Ariel Xiang
Regulation Number890.3860
Classification Product Code
ITI  
Date Received05/22/2025
Decision Date 10/06/2025
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
-
-