Product Code: DWL FDA class 2 21 CFR 880.5780

Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)

General Hospital

The Medical Support Stocking is a non-invasive device worn on the legs to apply graduated compression, preventing the pooling of venous blood in the lower extremities and reducing the risk of deep vein thrombosis, edema, or venous insufficiency. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DWL and it is regulated under 21 CFR 880.5780 within the General Hospital medical specialty.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: DWL
Device Class: FDA class 2
Regulation Number: 880.5780
Medical Specialty: General Hospital
Review Panel: HO
Submission Type: 4

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 64 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K141127	MEDLINE ANTI-EMBOLISM STOCKING	Aug 21, 2014	Substantially Equivalent	Medline Industries, Inc.
K131496	BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE)	Jul 10, 2013	Substantially Equivalent	Bsn Medical, Inc.
K122485	ENCIRCLE COMPRESSION THERAPY STOCKING	Apr 23, 2013	Substantially Equivalent	Encircle Medical Devices , Ltd.
K123820	BOSSONG HOSIERY MEDICAL COMPRESSION STOCKINGS 8-15 MMHG, BOSSONG HOSIERY ANTI-EMBOLISM STOCKINGS 10-20 MMHG, BOSSONG HOS	Apr 02, 2013	Substantially Equivalent	Bossong Hosiery Mills, Inc.
K123085	FUTURO (TM) TRAVEL KNEE-HIGHS; FUTURO (TM) TRAVEL SOCKS; FUTURO (TM) TRAVEL STOCKINGS; FUTURO (TM) TRAVEL PANTYHOSE	Dec 20, 2012	Substantially Equivalent	3M Company
K123561	ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS	Dec 18, 2012	Substantially Equivalent	Bsn Medical, Inc.
K123398	DR. SCHOLL'S COMPRESSION SOCKS	Dec 18, 2012	Substantially Equivalent	Renfro Corporation
K121106	TRUFORM READY-TO-WEAR COMPRESSION ARM SLEECE TRUFORM READY-TO-WEAR COMPRESSION GAUNTLET	Apr 27, 2012	Substantially Equivalent	Surgical Appliance Industries, Inc.
K112769	CURAD COMPRESSION HOSIERY	Mar 01, 2012	Substantially Equivalent	Medline Industries, Inc.
K111662	VENOTRAIN CURAFLOW	Oct 04, 2011	Substantially Equivalent	Bauerfeind AG
K101614	HEELSAFE DVT HOSE, MODELS 00800-00804, 00805-00809	Jan 13, 2011	Substantially Equivalent	Dm Systems, Incorporated
K101224	SAPHENAMEDICAL ANTI-EMBOLISM STOCKINGS	Dec 03, 2010	Substantially Equivalent	Griffiths and Nielsen, Ltd.
K101906	SHAPE TO FIT COMPRESSION WEAR	Sep 17, 2010	Substantially Equivalent	Tsung Hau Technology Co., Ltd.
K092892	1-M GRADUATED COMPRESSION ANTI-EMBOLISM STOCKING, MODEL SS-811, SS-508, SS-613	Aug 03, 2010	Substantially Equivalent	I-Ming Sanitary Materials Co., Ltd.
K090921	ANTI-EMBOLISM STOCKINGS, MODELS 71055-00000-02, 71057-00000-02, 71059-00000-02, 71064-00000-02 & 71065-00000-02	Dec 18, 2009	Substantially Equivalent	Beiersdorf, Inc.
K091141	THERAFIRM ANTI-EMBOLISM STOCKINGS, THERAFIRM MEN'S AND WOMEN'S TROUSER SOCKS	Jul 24, 2009	Substantially Equivalent	Knit-Rite, Inc.
K062873	SUNPOLAR HEALTHLINE, MODEL 100; COMPFRESH, MODEL 200; NATUREX , MODEL 300; AND IHEALTH, MODEL 400 STOCKINGS	Mar 20, 2007	Substantially Equivalent	E.C.I. USA Corporation
K061411	TORBOT VASCULAR COMPRESSION GARMENTS	Oct 18, 2006	Substantially Equivalent	Torbut Group, Inc.
K051324	MEDI BUTLER	Dec 05, 2005	Substantially Equivalent	Medi USA, LP
K040353	FLIGHT SOCK	Mar 11, 2004	Substantially Equivalent	Ssl Americas, Inc.
K032325	JOBST TRAVEL SOCKS	Aug 28, 2003	Substantially Equivalent	Bsn-Jobst, Inc.
K022233	HYDROBOOT	Aug 12, 2002	Substantially Equivalent	Incappe, Inc.
K020538	BOEHRINGER LABORATORIES PNEUMATIC AMBULATORY COMPRESSION SYSTEM 8200 SERIES	May 15, 2002	Substantially Equivalent	Boehringer Laboratories
K021102	DM SLEEVE	May 08, 2002	Substantially Equivalent	Emily Iker M.D., A.P.C.
K020592	ALBAHEALTH C.A.L.M. SLEEVE, MODEL 59001	Apr 03, 2002	Substantially Equivalent	Alba-Waldensian, Inc.
K013852	JOBST READY-TO-WEAR GAUNTLET	Jan 28, 2002	Substantially Equivalent	Bsn-Jobst, Inc.
K001300	D. R. MEDICAL CONTROLLED PRESSURE GARMENTS	Aug 30, 2000	Substantially Equivalent	Confection Medicale D.R., Inc.
K991570	JOBST READY-TO-WEAR ARM SLEEVES	Aug 20, 1999	Substantially Equivalent	Beiersdorf-Jobt, Inc.
K981296	GEEN MEDISOX	May 29, 1998	Substantially Equivalent	Geen Healthcare, Inc.
K964103	OLYMPIQUE MEDICAL SUPPORT HOSE AND STOCKINGS	Jan 06, 1997	Substantially Equivalent	Tournier-Bottu S.A.
K963573	ELVAREX	Oct 16, 1996	Substantially Equivalent	Jobst A Beiersdorf Co.
K960931	CAROLINA NARROW FABRIC COMPANY OPEN TOE ANTI-EMBOLISM STOCKING	May 23, 1996	Substantially Equivalent	Carolina Narrow Fabric Co.
K961177	CAROLINA NARROW FABRIC COMPANY CLOSED TOE ANTI-EMBOLISM STOCKING	Apr 15, 1996	Substantially Equivalent	Carolina Narrow Fabric Co.
K955138	ANTI-EM/GP STOCKINGS	Dec 13, 1995	Substantially Equivalent	Jobst Institute, Inc.
K954295	MARLENE STOCKINGS & TIGHTS	Nov 08, 1995	Substantially Equivalent	Professional Products, Inc.
K951234	MEDICAL SUPPORT STOCKINGS	May 18, 1995	Substantially Equivalent	Jobst A Beiersdorf Co.
K943734	MEDICAL SUPPORT STOCKINGS 2001/2002	Oct 19, 1994	Substantially Equivalent	Julius Zorn, Inc.
K941926	MEDI STRUMPF	Jun 15, 1994	Substantially Equivalent	Medi USA, LP
K925154	JOBST-CUSTOM	Apr 04, 1994	Substantially Equivalent	Jobst Institute, Inc.
K925643	RX FIT MEDICAL STOCKINGS	Dec 06, 1993	Substantially Equivalent	Elastic Therapy, Inc.
K925417	KENDALL HOME RX THERAPEUTIC STOCKING	Jun 04, 1993	Substantially Equivalent	Kendall Healthcare Products Co. Div.Of Tyco Health
K920444	ULTIMATE	Apr 20, 1992	Substantially Equivalent	Jobst Institute, Inc.
K905413	JUZO-RESPIRA ANTI-EMBOLISM STOCKING	May 17, 1991	Substantially Equivalent	Julius Zorn, Inc.
K905631	COMPRINET, COMTESSE AND BELLAVAR STOCKINGS	Mar 07, 1991	Substantially Equivalent	Jobst Institute, Inc.
K902497	SCD THERAPEUTIC STOCKING SYSTEM	Aug 15, 1990	Substantially Equivalent	Kendall Healthcare Products Co. Div.Of Tyco Health
K894071	COMFORT SHEER FIRM AND SHEER SUPPORT PANTYHOSE	Oct 18, 1989	Substantially Equivalent	Sara Lee Corp.
K892867	ULCERCARE	Jul 20, 1989	Substantially Equivalent for Some Indications	Jobst Institute, Inc.
K883186	WRIGHT GRADIENT PRESSURE SUPPORT STOCKINGS	Nov 21, 1988	Substantially Equivalent	Wright Linear Pump, Inc.
K883633	ULTRACARE	Oct 18, 1988	Substantially Equivalent	Jobst Institute, Inc.
K873280	ENHANCE SUPPORT HOSE	Oct 09, 1987	Substantially Equivalent	Kimberly-Clark Corp.
K863699	SHEER ENERGY, ACTIVE & SILKY SUPPORT PANTY HOSE	Feb 04, 1987	Substantially Equivalent	Hanes Group
K860826	VENOTRAIN COLOR COMPRESSION STOCKINGS & PANTYHOSE	Jun 18, 1986	Substantially Equivalent	Bauerfeind GmbH & Co.
K854428	VASC-EZ	Feb 13, 1986	Substantially Equivalent	Barton-Carey Medical Products Co.
K842708	MED. SUPPORT STOCKING-VENOFIT LASTOFLEX	Oct 09, 1984	Substantially Equivalent	Kundt + Co. AG
K841252	GLATTELAST COMPRESSION PANTY HOSE	Jun 27, 1984	Substantially Equivalent	Baurs Krey Assoc., Inc.
K841215	GLATTELAST COMPRESSION STOCKINGS	Jun 07, 1984	Substantially Equivalent	Baurs Krey Assoc., Inc.
K840335	SHEER ENERGY PANTY HOSE	May 25, 1984	Substantially Equivalent	Leggs Products, Inc.
K832273	SURGICAL STOCKINGS	Oct 19, 1983	Substantially Equivalent	Wells Johnson Co.
K832609	A.V.R. KNEE LENGTH THERAPEUTIC STOCK-	Sep 12, 1983	Substantially Equivalent	The Kendal Co.
K830697	VENES HIGH COMPRESSION MEDICAL STOCK-	Apr 30, 1983	Substantially Equivalent	Futuro Div. Jung Corp.
K830696	VENES ANTI EMBOLISM STOCKINGS	Mar 31, 1983	Substantially Equivalent	Futuro Div. Jung Corp.
K823737	MADE-TO-MEASURE SURGICAL ELASTIC SUPPORT	Jan 12, 1983	Substantially Equivalent	Gotfried Medical, Inc.
K822446	AES STOCKINGS	Aug 27, 1982	Substantially Equivalent	Rampon Products
K811085	VENES II	May 01, 1981	Substantially Equivalent	Jung Products, Inc.