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 K262553
Device Name MOBILITY SCOOTER (YQ-401,YQ- 401A,YQ-403,YQ-403A)
Applicant
Zhejiang Kailang Technology Co., Ltd.
5th Floor, Bldg. 1, #366 Huachuan Rd., Xicheng Subdistrict,
Yongkang,  CN
Applicant Contact Yongda Mei Mei
Correspondent
Shanghai Sungo Management Consulting Co., Ltd.
Rm. 1401, Dongfang Bldg., 1500# Century Ave., Shanghai 20012
Shanghai,  CN
Correspondent Contact Eva Li
Regulation Number890.3800
Classification Product Code
INI  
Date Received07/24/2026
Decision Date 09/29/2026
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
-
-