Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- BRZSet, Blood Transfusion2Product Code
- BWJLocator, Acupuncture Point2Product Code
- CAKMicrofilter, Blood Transfusion2Product Code
- DWLStocking, Medical Support (To Prevent Pooling Of Blood In Legs)2Product Code
- K141127MEDLINE ANTI-EMBOLISM STOCKING2Cleared 510(K)
- K131496BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE)2Cleared 510(K)
- K122485ENCIRCLE COMPRESSION THERAPY STOCKING2Cleared 510(K)
- K123820BOSSONG HOSIERY MEDICAL COMPRESSION STOCKINGS 8-15 MMHG, BOSSONG HOSIERY ANTI-EMBOLISM STOCKINGS 10-20 MMHG, BOSSONG HOS2Cleared 510(K)
- K123085FUTURO (TM) TRAVEL KNEE-HIGHS; FUTURO (TM) TRAVEL SOCKS; FUTURO (TM) TRAVEL STOCKINGS; FUTURO (TM) TRAVEL PANTYHOSE2Cleared 510(K)
- K123561ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS2Cleared 510(K)
- K123398DR. SCHOLL'S COMPRESSION SOCKS2Cleared 510(K)
- K121106TRUFORM READY-TO-WEAR COMPRESSION ARM SLEECE TRUFORM READY-TO-WEAR COMPRESSION GAUNTLET2Cleared 510(K)
- K112769CURAD COMPRESSION HOSIERY2Cleared 510(K)
- K111662VENOTRAIN CURAFLOW2Cleared 510(K)
- K101614HEELSAFE DVT HOSE, MODELS 00800-00804, 00805-008092Cleared 510(K)
- K101224SAPHENAMEDICAL ANTI-EMBOLISM STOCKINGS2Cleared 510(K)
- K101906SHAPE TO FIT COMPRESSION WEAR2Cleared 510(K)
- K0928921-M GRADUATED COMPRESSION ANTI-EMBOLISM STOCKING, MODEL SS-811, SS-508, SS-6132Cleared 510(K)
- K090921ANTI-EMBOLISM STOCKINGS, MODELS 71055-00000-02, 71057-00000-02, 71059-00000-02, 71064-00000-02 & 71065-00000-022Cleared 510(K)
- K091141THERAFIRM ANTI-EMBOLISM STOCKINGS, THERAFIRM MEN'S AND WOMEN'S TROUSER SOCKS2Cleared 510(K)
- K062873SUNPOLAR HEALTHLINE, MODEL 100; COMPFRESH, MODEL 200; NATUREX , MODEL 300; AND IHEALTH, MODEL 400 STOCKINGS2Cleared 510(K)
- K061411TORBOT VASCULAR COMPRESSION GARMENTS2Cleared 510(K)
- K051324MEDI BUTLER2Cleared 510(K)
- K040353FLIGHT SOCK2Cleared 510(K)
- K032325JOBST TRAVEL SOCKS2Cleared 510(K)
- K022233HYDROBOOT2Cleared 510(K)
- K020538BOEHRINGER LABORATORIES PNEUMATIC AMBULATORY COMPRESSION SYSTEM 8200 SERIES2Cleared 510(K)
- K021102DM SLEEVE2Cleared 510(K)
- K020592ALBAHEALTH C.A.L.M. SLEEVE, MODEL 590012Cleared 510(K)
- K013852JOBST READY-TO-WEAR GAUNTLET2Cleared 510(K)
- K001300D. R. MEDICAL CONTROLLED PRESSURE GARMENTS2Cleared 510(K)
- K991570JOBST READY-TO-WEAR ARM SLEEVES2Cleared 510(K)
- K981296GEEN MEDISOX2Cleared 510(K)
- K964103OLYMPIQUE MEDICAL SUPPORT HOSE AND STOCKINGS2Cleared 510(K)
- K963573ELVAREX2Cleared 510(K)
- K960931CAROLINA NARROW FABRIC COMPANY OPEN TOE ANTI-EMBOLISM STOCKING2Cleared 510(K)
- K961177CAROLINA NARROW FABRIC COMPANY CLOSED TOE ANTI-EMBOLISM STOCKING2Cleared 510(K)
- K955138ANTI-EM/GP STOCKINGS2Cleared 510(K)
- K954295MARLENE STOCKINGS & TIGHTS2Cleared 510(K)
- K951234MEDICAL SUPPORT STOCKINGS2Cleared 510(K)
- K943734MEDICAL SUPPORT STOCKINGS 2001/20022Cleared 510(K)
- K941926MEDI STRUMPF2Cleared 510(K)
- K925154JOBST-CUSTOM2Cleared 510(K)
- K925643RX FIT MEDICAL STOCKINGS2Cleared 510(K)
- K925417KENDALL HOME RX THERAPEUTIC STOCKING2Cleared 510(K)
- K920444ULTIMATE2Cleared 510(K)
- K905413JUZO-RESPIRA ANTI-EMBOLISM STOCKING2Cleared 510(K)
- K905631COMPRINET, COMTESSE AND BELLAVAR STOCKINGS2Cleared 510(K)
- K902497SCD THERAPEUTIC STOCKING SYSTEM2Cleared 510(K)
- K894071COMFORT SHEER FIRM AND SHEER SUPPORT PANTYHOSE2Cleared 510(K)
- K892867ULCERCARE2Cleared 510(K)
- K883186WRIGHT GRADIENT PRESSURE SUPPORT STOCKINGS2Cleared 510(K)
- K883633ULTRACARE2Cleared 510(K)
- K873280ENHANCE SUPPORT HOSE2Cleared 510(K)
- K863699SHEER ENERGY, ACTIVE & SILKY SUPPORT PANTY HOSE2Cleared 510(K)
- K860826VENOTRAIN COLOR COMPRESSION STOCKINGS & PANTYHOSE2Cleared 510(K)
- K854428VASC-EZ2Cleared 510(K)
- K842708MED. SUPPORT STOCKING-VENOFIT LASTOFLEX2Cleared 510(K)
- K841252GLATTELAST COMPRESSION PANTY HOSE2Cleared 510(K)
- K841215GLATTELAST COMPRESSION STOCKINGS2Cleared 510(K)
- K840335SHEER ENERGY PANTY HOSE2Cleared 510(K)
- K832273SURGICAL STOCKINGS2Cleared 510(K)
- K832609A.V.R. KNEE LENGTH THERAPEUTIC STOCK-2Cleared 510(K)
- K830697VENES HIGH COMPRESSION MEDICAL STOCK-2Cleared 510(K)
- K830696VENES ANTI EMBOLISM STOCKINGS2Cleared 510(K)
- K823737MADE-TO-MEASURE SURGICAL ELASTIC SUPPORT2Cleared 510(K)
- K822446AES STOCKINGS2Cleared 510(K)
- K811085VENES II2Cleared 510(K)
- FMFSyringe, Piston2Product Code
- FMGStopcock, I.V. Set2Product Code
- FMINeedle, Hypodermic, Single Lumen2Product Code
- FMSBed, Pediatric Open Hospital2Product Code
- FMTWarmer, Infant Radiant2Product Code
- FMZIncubator, Neonatal2Product Code
- FNGLift, Patient, Ac-Powered2Product Code
- FNJBed, Manual1Product Code
- FNKBed, Hydraulic, Adjustable Hospital1Product Code
- FNLBed, Ac-Powered Adjustable Hospital2Product Code
- FNMMattress, Air Flotation, Alternating Pressure2Product Code
- FNNNipple, Lambs Feeding1Product Code
- FODDevice, Occlusion, Umbilical1Product Code
- FOHMattress, Water, Temperature Regulated1Product Code
- FOKPad, Neonatal Eye1Product Code
- FOSCatheter, Umbilical Artery2Product Code
- FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days2Product Code
- FPASet, Administration, Intravascular2Product Code
- FPBFilter, Infusion Line2Product Code
- FPKTubing, Fluid Delivery2Product Code
- FPLIncubator, Neonatal Transport2Product Code
- FQHLavage, Jet2Product Code
- FQJSupport, Scrotal, Therapeutic1Product Code
- FQKBinder, Perineal1Product Code
- FQLStocking, Medical Support (For General Medical Purposes)1Product Code
- FQMBandage, Elastic1Product Code
- FRFCleaner, Air, Medical Recirculating2Product Code
- FRLFiber, Medical, Absorbent1Product Code
- FRNPump, Infusion2Product Code
- FRPHolder, Infant Position1Product Code
- FRRChamber, Reverse Isolation, Patient Care2Product Code
- FSALift, Patient, Non-Ac-Powered1Product Code
- FSDBinder, Abdominal1Product Code
- HEFBinder, Breast1Product Code
- HFSShield, Nipple1Product Code
- IKYMattress, Flotation Therapy, Non-Powered1Product Code
- KMKDevice, Intravascular Catheter Securement1Product Code
- KMOBinder, Elastic1Product Code
- KPEContainer, I.V.2Product Code
- KYPSnake Bite Suction Kit1Product Code
- KYQKit, Chemical Snake-Bite3Product Code
- KZDInfusor, Pressure, For I.V. Bags1Product Code
- KZEInjector, Fluid, Non-Electrically Powered2Product Code
- LBIUnit, Neonatal Phototherapy2Product Code
- LDRController, Infusion, Intravascular, Electronic2Product Code
- LGMChamber, Patient Isolation2Product Code
- LGNChamber, Patient Transport Isolation2Product Code
- LGZWarmer, Thermal, Infusion Fluid2Product Code
- LHFWarmer, Microwave, Infusion Fluid2Product Code
- LHISet, I.V. Fluid Transfer2Product Code
- LJLDetectors And Removers, Lice, (Including Combs)1Product Code
- LJSCatheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days2Product Code
- LJTPort & Catheter, Implanted, Subcutaneous, Intravascular2Product Code
- LLIBed, Therapeutic, Ac-Powered, Adjustable Home-Use2Product Code
- LLKLegging, Compression, Non-Inflatable2Product Code
- LZHPump, Infusion, Enteral2Product Code
- MDRBinder, Medical, Therapeutic1Product Code
- MEAPump, Infusion, Pca2Product Code
- MEBPump, Infusion, Elastomeric2Product Code
- MEGSyringe, Antistick2Product Code
- MHCNeedle, Interosseous2Product Code
- MHDPump, Infusion, Gallstone Dissolution2Product Code
- MJFCheck Valve, Retrograde Flow (In-Line)2Product Code
- MMKContainer, Sharps2Product Code
- MQXNeedle, Acupuncture, Single Use2Product Code
- MRZAccessories, Pump, Infusion2Product Code
- MZRTopical Approximation System1Product Code
- NEPSystem/Device, Pharmacy Compounding2Product Code
- NGTSaline, Vascular Access Flush2Product Code
- NKKNeedle, Hypodermic, Single Lumen, Reprocessed2Product Code
- NKNSyringe, Piston, Reprocessed2Product Code
- NRWStimulator, Intramuscular, Automatic2Product Code
- NSCInjector, Pen2Product Code
- NTCNursing Pad, Hydrogel1Product Code
- NTXNursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68)1Product Code
- NXHNursing Pad, Cohesive Gel1Product Code
- NZGBassinet, Hospital2Product Code
- NZWHeparin, Vascular Access Flush2Product Code
- NZXWater, Vascular Access Flush2Product Code
- OBKPort, Protector/Cushion2Product Code
- ODIAdministration Set Docking Station2Product Code
- ODYTunneled Catheter Remover2Product Code
- OJAIntravenous Extension Tubing Set2Product Code
- OKCImplanted Subcutaneous Securement Catheter2Product Code
- OKEPort Introducer Kit2Product Code
- OKLIntravascular Administration Set, Automated Air Removal System2Product Code
- OMFPercutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position2Product Code
- ONBClosed Antineoplastic And Hazardous Drug Reconstitution And Transfer System2Product Code
- ONMRadiant Infant Warmer Cabinet2Product Code
- PUKAdministration Set Securement Device1Product Code
- OPPPump, Infusion, Insulin Bolus2Product Code
- OSIBariatric Bed2Product Code
- OUWInfant Positioner, Rx, Use In Highly Monitored Setting1Product Code
- OWLPeripheral Catheter Insertion Kit2Product Code
- PDHBlanket, Neonatal Phototherapy2Product Code
- PEFHeparin Flush In 0.45% Sodium Chloride2Product Code
- PEZCentral Venous Catheter Dressing Change Kit2Product Code
- PHCInfusion Safety Management Software2Product Code
- PKPImmunoglobulin G (Igg) Infusion System2Product Code
- PMSPeripheral Intravenous (Piv) Infiltration Monitor2Product Code
- PNDMidline Catheter2Product Code
- POQBlood Transfusion Kit2Product Code
- PORParenteral Administration Kit2Product Code
- PQHIodinated Contrast Media Transfer Tubing Set2Product Code
- PQXEpinephrine Syringe2Product Code
- PRNPediatric Position Holder1Product Code
- PTDSubcutaneous Implanted Apheresis Port2Product Code
- PTINon-Coring (Huber) Needle2Product Code
- PUNLice Removal Kit Containing A Solution1Product Code
- PURVacuum Syringe2Product Code
- PVZNon-Stainless Steel Needle2Product Code
- PWHAdministrations Sets With Neuraxial Connectors2Product Code
- PWNBaby Care Kit2Product Code
- PWOBlood Administration Kit2Product Code
- PWQBuret Administration Intravenous Kit2Product Code
- PWRCatheter Repair Kit2Product Code
- PWXInsect Sting Emergency Kit1Product Code
- PWYLumbar Puncture Tray (Adult & Pediatric)2Product Code
- PXBPercutaneous Introducer Kit2Product Code
- PXIThoracentesis Tray2Product Code
- PXJUmbilical Catheter Insertion Tray2Product Code
- PXKVascular Access Port Kit2Product Code
- PXLVenipuncture Kit2Product Code
- PYRNeuraxial Administration Set - Intrathecal Delivery2Product Code
- PZWCatheter Access Cover, Tamper-Resistant2Product Code
- QBLPiston Syringe Lever2Product Code
- QDMMidazolam Syringe2Product Code
- QEHPiston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact2Product Code
- QJYInfusion Pump, Drug Specific, Pharmacy-Filled2Product Code
- QLFOn-Body Injector2Product Code
- QLYOphthalmic Syringe2Product Code
- QMTPrep Kit – Vaccine Injection2Product Code
- QNQLow Dead Space Piston Syringe2Product Code
- QNSLow Dead Space Needle, Single Lumen, Hypodermic2Product Code
- QOGInjection Data Capture Device2Product Code
- QOIIntravenous Catheter Force-Activated Separation Device.2Product Code
- QTISaline Vascular Access Flush With Integrated Alcohol Disinfectant Device2Product Code
- QYMOphthalmic Needle2Product Code
- SCLAllergen And Vaccine Delivery Needles2Product Code
- SEFCentral Venous Catheter With Manual Insertion System2Product Code
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
SUNPOLAR HEALTHLINE, MODEL 100; COMPFRESH, MODEL 200; NATUREX , MODEL 300; AND IHEALTH, MODEL 400 STOCKINGS
- Page Type
- Cleared 510(K)
- 510(k) Number
- K062873
- 510(k) Type
- Traditional
- Applicant
- E.C.I. USA CORPORATION
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/20/2007
- Days to Decision
- 176 days
- Submission Type
- Summary