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510(k) K121106

TRUFORM READY-TO-WEAR COMPRESSION ARM SLEECE TRUFORM READY-TO-WEAR COMPRESSION GAUNTLET by Surgical Appliance Industries, Inc. — Product Code DWL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 2012
Date Received
April 12, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
Device Class
Class II
Regulation Number
880.5780
Review Panel
HO
Submission Type

Other clearances by Surgical Appliance Industries, Inc.

  • K821682 — TRUNCAL ORTHOSIS (June 24, 1982)
  • K813416 — EXTERNAL BREAST PROSTHESIS (January 18, 1982)
  • K812423 — NEOPRENE KNEE SUPPORT (September 14, 1981)
  • K812401 — CRUCIFORM ANTERIOR SPINAL HYPEREXTEN. O (September 14, 1981)
  • K812422 — CUSTOM CONTOUR LUMBOSACRAL ORTHOSIS (September 14, 1981)
  • K811690 — ANKLE-FOOT CAST/SPLINT (June 25, 1981)
  • K811689 — CYLINDER KNEE CAST/SPLINT (June 25, 1981)
  • K811494 — LUMBO-SACRAL FLEXION ORTHOSIS (June 16, 1981)

Other clearances for product code DWL

  • K141127 — MEDLINE ANTI-EMBOLISM STOCKING (August 21, 2014)
  • K131496 — BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE) (July 10, 2013)
  • K122485 — ENCIRCLE COMPRESSION THERAPY STOCKING (April 23, 2013)
  • K123820 — BOSSONG HOSIERY MEDICAL COMPRESSION STOCKINGS 8-15 MMHG, BOSSONG HOSIERY ANTI-EM (April 2, 2013)
  • K123085 — FUTURO (TM) TRAVEL KNEE-HIGHS; FUTURO (TM) TRAVEL SOCKS; FUTURO (TM) TRAVEL STOC (December 20, 2012)
  • K123398 — DR. SCHOLL'S COMPRESSION SOCKS (December 18, 2012)
  • K123561 — ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS (December 18, 2012)
  • K112769 — CURAD COMPRESSION HOSIERY (March 1, 2012)
  • K111662 — VENOTRAIN CURAFLOW (October 4, 2011)
  • K101614 — HEELSAFE DVT HOSE, MODELS 00800-00804, 00805-00809 (January 13, 2011)