Model Sw-103 Solitans Stimulator

• • Terminated Z-0194-2007 FDA Unclassified (pre-2012) ·initiated 31 Aug 2006 ·on shared 510(k) K904264

  The chain holding the device gantry in position may break.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K904264 ↗

FDA Product Code

GZJ

FDA applicant

Medical Consultants Intl. , Ltd.

Device Class

Class II

Regulation

21 CFR Part 882.5890

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Medi Model SBL502-B (Liss Body Stimulator) Zero Dc

  Class II

  FDA 510(k) K902976 Active Cleared 7 Sep 1990

• Liss Cranial Stimulator Model SBL202-B Open recall

  Class II

  FDA 510(k) K903654 Active Cleared 4 Oct 1990

• Liss Body Stimulator Model SBL501-M

  Class II

  FDA 510(k) K896226 Active Cleared 10 Apr 1990

• Liss Cranial Stimulator Model SBL201-M

  Class II

  FDA 510(k) K894515 Active Cleared 3 May 1990

• Medi Liss Dental Analgesia Device (SBL601)

  Unclassified

  FDA 510(k) K900731 Active Cleared 17 Dec 1990