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510(k) K073386

JOINT STIM, MODEL 1000 by Pain Management Technologies — Product Code NYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2008
Date Received
December 3, 2007
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 Pain Management Technologies

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  • K083494 — ULTIMA FIVE (January 6, 2009)
  • K030375 — SOFT-TOUCH TENS ELECTRODE (May 5, 2003)
  • K011411 — SELF-ADHESIVE ELECTRODES (June 13, 2001)

Other clearances for product code NYN

  • K142236 — BioniCare Hand System (March 23, 2015)
  • K111557 — X-FORCE (November 10, 2011)
  • K062325 — RS-4I MUSCLE STIMULATOR FAMILY (April 13, 2007)
  • 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)