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, Muscle, Powered
510(k) Number K020130
Device Name ROLOR POWERED MUSCLE STIMULATOR, MODEL GP-8016M
Applicant
Rolor Electronics Corp.
# 58, Fu-Chiun St.
Hsin-Chu City,  TW
Applicant Contact JEN KE-MIN
Correspondent
Rolor Electronics Corp.
# 58, Fu-Chiun St.
Hsin-Chu City,  TW
Correspondent Contact JEN KE-MIN
Regulation Number890.5850
Classification Product Code
IPF  
Date Received01/15/2002
Decision Date 12/02/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-