FDA 510(k) Applications for Medical Device Product Code "DWL"
(Stocking, Medical Support (To Prevent Pooling Of Blood In Legs))

FDA 510(k) Number Applicant Device Name Decision Date
K123085 3M COMPANY FUTURO (TM) TRAVEL KNEE-HIGHS; FUTURO (TM) TRAVEL SOCKS; FUTURO (TM) TRAVEL STOCKINGS; FUTURO (TM) TRAVEL PANTYHOSE 12/20/2012
K020592 ALBA-WALDENSIAN, INC. ALBAHEALTH C.A.L.M. SLEEVE, MODEL 59001 04/03/2002
K111662 BAUERFEIND AG VENOTRAIN CURAFLOW 10/04/2011
K991570 BEIERSDORF-JOBT, INC. JOBST READY-TO-WEAR ARM SLEEVES 08/20/1999
K090921 BEIERSDORF, INC. ANTI-EMBOLISM STOCKINGS, MODELS 71055-00000-02, 71057-00000-02, 71059-00000-02, 71064-00000-02 & 71065-00000-02 12/18/2009
K020538 BOEHRINGER LABORATORIES BOEHRINGER LABORATORIES PNEUMATIC AMBULATORY COMPRESSION SYSTEM 8200 SERIES 05/15/2002
K123820 BOSSONG HOSIERY MILLS, INC BOSSONG HOSIERY MEDICAL COMPRESSION STOCKINGS 8-15 MMHG, BOSSONG HOSIERY ANTI-EMBOLISM STOCKINGS 10-20 MMHG, BOSSONG HOS 04/02/2013
K131496 BSN MEDICAL, INC. BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE) 07/10/2013
K123561 BSN MEDICAL, INC. ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS 12/18/2012
K013852 BSN-JOBST, INC. JOBST READY-TO-WEAR GAUNTLET 01/28/2002
K032325 BSN-JOBST, INC. JOBST TRAVEL SOCKS 08/28/2003
K961177 CAROLINA NARROW FABRIC CO. CAROLINA NARROW FABRIC COMPANY CLOSED TOE ANTI-EMBOLISM STOCKING 04/15/1996
K960931 CAROLINA NARROW FABRIC CO. CAROLINA NARROW FABRIC COMPANY OPEN TOE ANTI-EMBOLISM STOCKING 05/23/1996
K001300 CONFECTION MEDICALE D.R., INC. D. R. MEDICAL CONTROLLED PRESSURE GARMENTS 08/30/2000
K101614 DM SYSTEMS, INCORPORATED HEELSAFE DVT HOSE, MODELS 00800-00804, 00805-00809 01/13/2011
K062873 E.C.I. USA CORPORATION SUNPOLAR HEALTHLINE, MODEL 100; COMPFRESH, MODEL 200; NATUREX , MODEL 300; AND IHEALTH, MODEL 400 STOCKINGS 03/20/2007
K021102 EMILY IKER M.D., A.P.C. DM SLEEVE 05/08/2002
K122485 ENCIRCLE MEDICAL DEVICES LTD. ENCIRCLE COMPRESSION THERAPY STOCKING 04/23/2013
K981296 GEEN HEALTHCARE, INC. GEEN MEDISOX 05/29/1998
K101224 GRIFFITHS AND NIELSEN LTD SAPHENAMEDICAL ANTI-EMBOLISM STOCKINGS 12/03/2010
K092892 I-MING SANITARY MATERIALS CO., LTD. 1-M GRADUATED COMPRESSION ANTI-EMBOLISM STOCKING, MODEL SS-811, SS-508, SS-613 08/03/2010
K022233 INCAPPE, INC. HYDROBOOT 08/12/2002
K963573 JOBST A BEIERSDORF CO. ELVAREX 10/16/1996
K091141 KNIT-RITE, INC. THERAFIRM ANTI-EMBOLISM STOCKINGS, THERAFIRM MEN'S AND WOMEN'S TROUSER SOCKS 07/24/2009
K051324 MEDI USA, LP MEDI BUTLER 12/05/2005
K141127 MEDLINE INDUSTRIES, INC. MEDLINE ANTI-EMBOLISM STOCKING 08/21/2014
K112769 MEDLINE, INDUSTRIES, INC. CURAD COMPRESSION HOSIERY 03/01/2012
K123398 RENFRO CORPORATION DR. SCHOLL'S COMPRESSION SOCKS 12/18/2012
K040353 SSL AMERICAS, INC. FLIGHT SOCK 03/11/2004
K121106 SURGICAL APPLIANCE INDUSTRIES, INC. TRUFORM READY-TO-WEAR COMPRESSION ARM SLEECE TRUFORM READY-TO-WEAR COMPRESSION GAUNTLET 04/27/2012
K061411 TORBUT GROUP, INC. TORBOT VASCULAR COMPRESSION GARMENTS 10/18/2006
K964103 TOURNIER-BOTTU S.A. OLYMPIQUE MEDICAL SUPPORT HOSE AND STOCKINGS 01/06/1997
K101906 TSUNG HAU TECHNOLOGY CO., LTD. SHAPE TO FIT COMPRESSION WEAR 09/17/2010


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