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 K203806
Device Name JWX-1 Plus (Navigo 16/Navigo 24)
Applicant
Yamaha Motor Co., Ltd.
2500 Shingai
Iwata,  JP 438-8501
Applicant Contact Michiyo Yamazaki
Correspondent
Yamaha Motor Co., Ltd.
2500 Shingai
Iwata,  JP 438-8501
Correspondent Contact Mikio Saitou
Regulation Number890.3860
Classification Product Code
ITI  
Date Received12/28/2020
Decision Date 05/21/2021
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
-
-