• 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, muscle, powered, for muscle conditioning
510(k) Number K201354
Device Name TENS & PMS
Hong Qiangxing (Shen Zhen) Electronics Limited
4F, Jingcheng Building, Xicheng Industrial Zone
Xixiang Road, Baoan
Shenzhen,  CN 518126
Applicant Contact Linda Liao
Shanghai CV Technology Co., Ltd.
Room 903, No. 19 Dongbao Road, Songjiang Area,
Shanghai,  CN 201613
Correspondent Contact Doris Dong
Regulation Number890.5850
Classification Product Code
Subsequent Product Code
Date Received05/21/2020
Decision Date 12/11/2020
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