• 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 K780402
Device Name POWER STRIDER
Applicant
Seidel Manufacturing, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Seidel Manufacturing, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.3860
Classification Product Code
ITI  
Date Received03/13/1978
Decision Date 05/12/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
-
-