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, For Pain Relief
510(k) Number K912178
Device Name BIO TENS 601, 606 AND 608 (3000)
Applicant
Skylark Device Co., Ltd.
12 Floor 34, Sec. 3 Chung Shan
N. Rd.
Taipei, Taiwan, R.O.C.,  TW
Applicant Contact CHEN
Correspondent
Skylark Device Co., Ltd.
12 Floor 34, Sec. 3 Chung Shan
N. Rd.
Taipei, Taiwan, R.O.C.,  TW
Correspondent Contact CHEN
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received05/16/1991
Decision Date 10/25/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-