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 K212092
Device Name Portable Folding Electric Wheelchair (Model: DC01)
Applicant
Anhui Jbh Medical Apparatus Co., Ltd.
# 116 Qicang Rd.
Mingguang City, Chuzhou,  CN 239400
Applicant Contact Yang Dandan
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
Rm. 1401, #1500, Century Ave., Pudong New District
Shanghai,  CN 200122
Correspondent Contact Ivy Wang
Regulation Number890.3860
Classification Product Code
ITI  
Date Received07/06/2021
Decision Date 05/06/2022
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
-
-