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 Stimulator, Electro-Acupuncture
510(k) Number K260230
Device Name Needle Stimulator (SDZ-IIB, SDZ-IIC, SDZ-III, SDZ-V)
Applicant
Suzhou Medical Appliance Factory
#18 Huatuo Rd., Sstt, 215163 Suzhou New District
Suzhou,  CN 215163
Applicant Contact Xuejiao Song
Correspondent
Abmed Medical Technology Pty, Ltd.
48/6 Herbert St.
St Leonards,  AU 2065
Correspondent Contact Boyle Wang
Classification Product Code
BWK  
Date Received01/26/2026
Decision Date 10/22/2026
Decision Substantially Equivalent (SESE)
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-