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 K221026
Device Name Power Wheelchair
Applicant
Zhejiang Innuovo Rehabilitation Devices Co.,Ltd
# 196 Industry Rd., Hengdian Movie Zone
Dongyang,  CN
Applicant Contact Leo Zheng
Correspondent
Shanghai Sungo Management Consulting Company Limited.
14th Floor, 1500# Central Ave.
Shanghai,  CN 200122
Correspondent Contact Ivy Wang
Regulation Number890.3860
Classification Product Code
ITI  
Date Received04/06/2022
Decision Date 07/01/2022
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
-
-