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 Massager, Powered Inflatable Tube
510(k) Number K251622
Device Name Hand Massager (SM004D)
Applicant
Ningbo Zhenhai Yihao Electronic Technology Co., Ltd.
Partial 3/F & Whole 2/F, Bldg. 2, # 766 Wenluo Rd.
Luotuo St., Zhenhai District
Ningbo,  CN
Applicant Contact Honglie Wang
Correspondent
Microkn Medical Technology Service (Shanghai) Co., Ltd.
Rm. 901, Huafa Center, 889 Pinglu Rd.
Jing'An District, Shanghai
Shanghai,  CN 200040
Correspondent Contact Owen He
Regulation Number890.5650
Classification Product Code
IRP  
Date Received05/28/2025
Decision Date 01/28/2026
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
-
-