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, Special Grade
510(k) Number K251570
Device Name Hippocampe Marathon and Trail
Applicant
Vipamat Sarl
3 Rue Gustave Eiffel
Ploemeur,  FR 56270
Applicant Contact Vincent Leroy
Correspondent
Rook Quality Systems, LLC
1155 Mount Vernon Hwy
Suite 800
Dunwoody,  GA  30338
Correspondent Contact Sarah Lacey Robbins
Regulation Number890.3880
Classification Product Code
IQC  
Date Received05/22/2025
Decision Date 06/23/2025
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
-
-