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 Vehicle, Motorized 3-Wheeled
510(k) Number K253643
Device Name Mobility Scooter (S3)
Applicant
Shenzhen Zhimahuaerkai Technology Co., Ltd.
Rm. 602, Bldg. F1, Tcl Science Park, #1001 Zhongshan
Garden Rd., Shuguang Community,Xili St.,Nanshan District
Shenzhen,  CN
Applicant Contact Xianwei Zhang
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, Dongfang Bldg., 1500# Century Ave.
Shanghai,  CN
Correspondent Contact Kiwi Xu
Regulation Number890.3800
Classification Product Code
INI  
Date Received11/19/2025
Decision Date 02/18/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-