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, Nerve, Transcutaneous, Over-The-Counter
510(k) Number K212918
Device Name Heat StimPlus
Applicant
Famidoc Technology Co., Ltd.
No.212 Yilong Road, Hexi Industrial Zone, Jinxia ,
Changan Town
Dongguan,  CN 523853
Applicant Contact Amos Zou
Correspondent
Famidoc Technology Co., Ltd.
No.212 Yilong Road, Hexi Industrial Zone, Jinxia ,
Changan Town
Dongguan,  CN 523853
Correspondent Contact Amos Zou
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NGX  
Date Received09/14/2021
Decision Date 12/13/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-