DWL · Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
General Hospital · 21 CFR 880.5780 · Class 2
Overview
| Product Code | DWL |
|---|---|
| Device Name | Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) |
| Regulation | 21 CFR 880.5780 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
Identification
Medical support stocking to prevent the pooling of blood in the legs: A medical support stocking to prevent the pooling of blood in the legs is a device that is constructed of elastic material and designed to apply controlled pressure to the leg and that is intended for use in the prevention of pooling of blood in the leg. Medical support stocking for general medical purposes: A medical support stocking for general medical purposes is a device that is constructed of elastic material and designed to apply controlled pressure to the leg and that is intended for medical purposes other than the prevention of pooling of blood in the leg.
Classification Rationale
For the medical support stocking to prevent the pooling of blood in the legs: Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9. For the medical support stocking for general medical purposes: Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.(b) *Medical support stocking for general medical purposes* —(1)*Identification.* A medical support stocking for general medical purposes is a device that is constructed of elastic material and designed to apply controlled pressure to the leg and that is intended for medical purposes other than the prevention of pooling of blood in the leg.(2) *Classification.* Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (20 of 64)
Showing 20 most recent of 64 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K141127 | MEDLINE ANTI-EMBOLISM STOCKING | Medline Industries, Inc. | Aug 21, 2014 | SESE |
| K131496 | BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE) | Bsn Medical, Inc. | Jul 10, 2013 | SESE |
| K122485 | ENCIRCLE COMPRESSION THERAPY STOCKING | Encircle Medical Devices , Ltd. | Apr 23, 2013 | SESE |
| K123820 | BOSSONG HOSIERY MEDICAL COMPRESSION STOCKINGS 8-15 MMHG, BOSSONG HOSIERY ANTI-EMBOLISM STOCKINGS 10-20 MMHG, BOSSONG HOS | Bossong Hosiery Mills, Inc. | Apr 2, 2013 | SESE |
| K123085 | FUTURO (TM) TRAVEL KNEE-HIGHS; FUTURO (TM) TRAVEL SOCKS; FUTURO (TM) TRAVEL STOCKINGS; FUTURO (TM) TRAVEL PANTYHOSE | 3M Company | Dec 20, 2012 | SESE |
| K123561 | ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS | Bsn Medical, Inc. | Dec 18, 2012 | SESE |
| K123398 | DR. SCHOLL'S COMPRESSION SOCKS | Renfro Corporation | Dec 18, 2012 | SESE |
| K121106 | TRUFORM READY-TO-WEAR COMPRESSION ARM SLEECE TRUFORM READY-TO-WEAR COMPRESSION GAUNTLET | Surgical Appliance Industries, Inc. | Apr 27, 2012 | SESE |
| K112769 | CURAD COMPRESSION HOSIERY | Medline Industries, Inc. | Mar 1, 2012 | SESE |
| K111662 | VENOTRAIN CURAFLOW | Bauerfeind AG | Oct 4, 2011 | SESE |
| K101614 | HEELSAFE DVT HOSE, MODELS 00800-00804, 00805-00809 | Dm Systems, Incorporated | Jan 13, 2011 | SESE |
| K101224 | SAPHENAMEDICAL ANTI-EMBOLISM STOCKINGS | Griffiths and Nielsen, Ltd. | Dec 3, 2010 | SESE |
| K101906 | SHAPE TO FIT COMPRESSION WEAR | Tsung Hau Technology Co., Ltd. | Sep 17, 2010 | SESE |
| K092892 | 1-M GRADUATED COMPRESSION ANTI-EMBOLISM STOCKING, MODEL SS-811, SS-508, SS-613 | I-Ming Sanitary Materials Co., Ltd. | Aug 3, 2010 | SESE |
| K090921 | ANTI-EMBOLISM STOCKINGS, MODELS 71055-00000-02, 71057-00000-02, 71059-00000-02, 71064-00000-02 & 71065-00000-02 | Beiersdorf, Inc. | Dec 18, 2009 | SESE |
| K091141 | THERAFIRM ANTI-EMBOLISM STOCKINGS, THERAFIRM MEN'S AND WOMEN'S TROUSER SOCKS | Knit-Rite, Inc. | Jul 24, 2009 | SESE |
| K062873 | SUNPOLAR HEALTHLINE, MODEL 100; COMPFRESH, MODEL 200; NATUREX , MODEL 300; AND IHEALTH, MODEL 400 STOCKINGS | E.C.I. USA Corporation | Mar 20, 2007 | SESE |
| K061411 | TORBOT VASCULAR COMPRESSION GARMENTS | Torbut Group, Inc. | Oct 18, 2006 | SESE |
| K051324 | MEDI BUTLER | Medi USA, LP | Dec 5, 2005 | SESE |
| K040353 | FLIGHT SOCK | Ssl Americas, Inc. | Mar 11, 2004 | SESE |
Top Applicants
- Jobst Institute, Inc. — 6 clearances
- Baurs Krey Assoc., Inc. — 2 clearances
- Bsn Medical, Inc. — 2 clearances
- Bsn-Jobst, Inc. — 2 clearances
- Carolina Narrow Fabric Co. — 2 clearances
