510(k) K062325

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

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 13, 2007
Date Received: August 9, 2006
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Stimulator, Electrical, Transcutaneous, For Arthritis
Device Class: Class II
Regulation Number: 882.5890
Review Panel: NE
Submission Type

Electrical stimulation unit with leads and cutaneous electrodes used to apply an electrical current through electrodes on patient's skin to provide relief of pain associated with arthritis (including osteoarthritis and rheumatoid arthritis).

Other clearances by Rs Medical

K112348 — RS-4I MUSCLE STIMULATOR (January 19, 2012)
K090951 — RS- LB LOW BACK CONDUCTIVE GARMENT, MODEL RS-LBM, RS-LBL, RS-FBG FULL BACK CONDU (June 5, 2009)
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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K111557 — X-FORCE (November 10, 2011)
K073386 — JOINT STIM, MODEL 1000 (July 30, 2008)
K052625 — BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000 (December 5, 2005)
K030332 — MODIFICATION TO BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000 (June 6, 2003)
K983228 — BIONICARE STIMILATOR SYSTEM, MODEL BIO-1000 (March 15, 1999)
K971437 — BIONICARE STIMULATOR SYSTEM. MODEL BIO-1000 (July 22, 1997)