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510(k) K142236

BioniCare Hand System by Vision Quest Industries, Inc. — Product Code NYN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 2015
Date Received
August 13, 2014
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 Vision Quest Industries, Inc.

  • K090532 — T.E.A.R. TECH3 (November 13, 2009)
  • K072799 — TARGET STERILE ELECTRODE (April 24, 2008)
  • K041092 — FAST START TENS, MODEL FS 3001 (July 1, 2004)
  • K030507 — T.E.A.R. TECH3 MODEL #44TT03 (May 20, 2003)
  • K982388 — SURGI STIM (September 14, 1998)

Other clearances for product code NYN

  • K111557 — X-FORCE (November 10, 2011)
  • K073386 — JOINT STIM, MODEL 1000 (July 30, 2008)
  • 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)