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 device, acupressure
510(k) Number K211823
Device Name Bonine Acupressure Bands
Applicant
WellSpring Pharmaceutical Corporation
5911 North Honore Avenue, Suite 211
Sarasota,  FL  34243
Applicant Contact Renee Davis Grandchamp
Correspondent
Drug Device Consulting
13014 N. Dale Mabry Hwy., #326
Tampa,  FL  33618
Correspondent Contact Mikel Alberdi
Classification Product Code
MVV  
Date Received06/14/2021
Decision Date 09/01/2021
Decision Substantially Equivalent (SESE)
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-