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510(k) K112348

RS-4I MUSCLE STIMULATOR by Rs Medical — Product Code IPF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 2012
Date Received
August 16, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Muscle, Powered
Device Class
Class II
Regulation Number
890.5850
Review Panel
PM
Submission Type

Other clearances by Rs Medical

  • K090951 — RS- LB LOW BACK CONDUCTIVE GARMENT, MODEL RS-LBM, RS-LBL, RS-FBG FULL BACK CONDU (June 5, 2009)
  • K062325 — RS-4I MUSCLE STIMULATOR FAMILY (April 13, 2007)
  • K032652 — RS-4I MUSCLE STIMULATOR FAMILY (September 12, 2003)
  • K021763 — RS2MI MUSCLE STIMULATOR FAMILY (June 13, 2002)
  • K000114 — RS-4M+MUSCLE STIMULATOR (August 10, 2000)
  • K990697 — RS-4V MUSCLE STIMULATOR (June 18, 1999)
  • K953136 — RS-4M (November 30, 1995)
  • K920388 — RS-1 NEUROMUSCULAR STIMULATOR (January 28, 1993)
  • K920389 — RS-2 NEUROMUSCULAR STIMULATOR (January 28, 1993)

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