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510(k) K052625

BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000 by Bionicare Medical Technologies, Inc. — Product Code NYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 2005
Date Received
September 23, 2005
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 Bionicare Medical Technologies, Inc.

  • K030332 — MODIFICATION TO BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000 (June 6, 2003)

Other clearances for product code NYN

  • K142236 — BioniCare Hand System (March 23, 2015)
  • K111557 — X-FORCE (November 10, 2011)
  • K073386 — JOINT STIM, MODEL 1000 (July 30, 2008)
  • K062325 — RS-4I MUSCLE STIMULATOR FAMILY (April 13, 2007)
  • 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)