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
- 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
- FLGCleaner, Ultrasonic, Medical Instrument1Product Code
- FLHWasher Of Body Waste Receptacles1Product Code
- FLICabinet, Ethylene-Oxide Gas Aerator2Product Code
- BRTRestraint, Patient, Conductive1Product Code
- BYYTube, Aspirating, Flexible, Connecting2Product Code
- BYZTrap, Sterile Specimen2Product Code
- CBCBottle, Collection And Trap, Breathing System (Uncalibrated)2Product Code
- CBDBottle, Collection, Breathing System (Calibrated)2Product Code
- FLESterilizer, Steam2Product Code
- FLFSterilizer, Ethylene-Oxide Gas2Product Code
- FMADepressor, Tongue, Non-Surgical1Product Code
- FMCPatient Examination Glove1Product Code
- FMEGown, Examination1Product Code
- FMLChair, Blood Donor1Product Code
- FMPProtector, Skin Pressure1Product Code
- FMQRestraint, Protective1Product Code
- K110377PROTECTIVE RESTRAINT1Cleared 510(K)
- K081264STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-0021Cleared 510(K)
- K080448CENTURION PROTECTIVE RESTRAINT, SCR SERIES1Cleared 510(K)
- K013239COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLES1Cleared 510(K)
- K010818INFANT LIMB HOLDER, MODELS 306080 & 3060811Cleared 510(K)
- K010644CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 9120251Cleared 510(K)
- K991591BIOTHANE PATIENT RESTRAINT1Cleared 510(K)
- K982178VAGABOND SOFT RESTRAINT SYSTEM1Cleared 510(K)
- K980640HEELBO WAIST AND CHEST VEST1Cleared 510(K)
- K972446PEDO CUSH PEDO CUDDLE1Cleared 510(K)
- K972046FULL BODY RESTRAINT SYSTEM1Cleared 510(K)
- K971948PATIENT RESTRAINT1Cleared 510(K)
- K972123PROTECTIVE RESTRAINT MODELS #302,440,750,850,AND9051Cleared 510(K)
- K972338PROTECTIVE RESTRAINT(MODELS #302,440,750 AND A30 X 30 BELT.1Cleared 510(K)
- K971742DEPUY ORTHOTECH HEAVY DUTY VEST RESTRAINT1Cleared 510(K)
- K971561PROVEST-PROTECTIVE RESTRAINT1Cleared 510(K)
- K971536RESTRAINTS (VESTS AND JACKETS)1Cleared 510(K)
- K970272PATIENT RESTRAINT1Cleared 510(K)
- K970275PATIENT RESTRAINTS1Cleared 510(K)
- K970274PATIENT RESTRAINTS1Cleared 510(K)
- K970273PATIENT RESTRAINTS1Cleared 510(K)
- K962327SEKURE SEAT ADULT PASSIVE RESTRAINING DEVICE1Cleared 510(K)
- K963466PEDIATRIC LIMB HOLDER1Cleared 510(K)
- K963474TUXEDO VEST RESTRAINT1Cleared 510(K)
- K963476DISPOSABLE LIMB HOLDER1Cleared 510(K)
- K963468RESTRICTIVE LIMB HOLDER1Cleared 510(K)
- K963467ROLL BELTS1Cleared 510(K)
- K963465PELVIC HOLDER1Cleared 510(K)
- K963906PATIENT RESTRAINTS1Cleared 510(K)
- K963547THE WRAP IMMOBILIZATION SYSTEM1Cleared 510(K)
- K963564PERSONAL LIMB HOLDER (24444-200,300,24444-KIT)1Cleared 510(K)
- K963559WRPAROUND LIMB HOLDER (24446,24446-350,24447-010,24449-010)1Cleared 510(K)
- K963552QUICK RELEASE LIMB HOLDER (24442,24442-050,24442-350)1Cleared 510(K)
- K963485SILICONE RUBBER CUFF/DISPOSABLE FLEECE LINER'S WEB TORSO RESRAINT,NYON LIMB HOLDER,VINYL LIMB HOLDER,NYLON BED RESTRAINS1Cleared 510(K)
- K963414MULTIPLE BELTS1Cleared 510(K)
- K963442JACKETS AND VESTS1Cleared 510(K)
- K963436RESTRAINT ACCESSORIES1Cleared 510(K)
- K963430PROTECTIVE RESTRAINT (VEST RESTRAINT)1Cleared 510(K)
- K963422PROTECTIVE RESTRAINT (PROTECTIVE MITT)1Cleared 510(K)
- K963421PROTECTIVE RESTRAINT (WAIST HOLDER)1Cleared 510(K)
- K963410POSEY STRAIGHT JACKETS1Cleared 510(K)
- K96377324457-010 SECURE ALL PELVIC HOLDER/24458-010 SECURE ALL BODY BELT1Cleared 510(K)
- K96355424448-010 SECURE-ALL FINGER CONTROL MITT1Cleared 510(K)
- K963556SECURE-ALL 1-PIECE BODY HOLDER, SMALL/MEDIUM (24451-010,020,24452-010,020,030)1Cleared 510(K)
- K963557SYSTEM 2 ZIPPERED BODY HOLDER, SMALL/MEDIUM 24453-010,24453-020,24453-0301Cleared 510(K)
- K963561ULTRA CARE VEST STYLE BODY HOLDER, SMALL (24455-010,020,030,040,24456-010,020,030,040)1Cleared 510(K)
- K963563ULTRACARE VEST STYLE BODY HOLDER WITH SAFETY SLEEVES, SMALL(24454-010,020,030,040,015,025,035,045,115,125,135,145)1Cleared 510(K)
- K963462COMFOR FOAM LIMB HOLDERS- SINGLE STRAP1Cleared 510(K)
- K963439PEDIATRIC LIMB HOLDERS1Cleared 510(K)
- K963411POSEY LAPTOP TRAYS1Cleared 510(K)
- K963437PELVIC HOLDERS1Cleared 510(K)
- K963453CFI RESTRAINT BELT (CFI-168) / CFI RESTRAINT BELT (CFI-4046)1Cleared 510(K)
- K963471SUPER SECURITY RESTRAINT1Cleared 510(K)
- K963473REUSABLE LIMB HOLDER1Cleared 510(K)
- K963478SLEEVED/SLEEVELESS VEST RESTRAINT1Cleared 510(K)
- K963472PEDIATRIC VEST RESTRAINT1Cleared 510(K)
- K963470CRISS-CROSS VEST RESTRAINT1Cleared 510(K)
- K963469MITTENS1Cleared 510(K)
- K963491STUCKEY STRAP-3 FINGER RESTRAINTS1Cleared 510(K)
- K963409POSEY HUGGER1Cleared 510(K)
- K963413MULTIPLE LIMB HOLDERS1Cleared 510(K)
- K963489WHEEL CHAIR ACCESSORY1Cleared 510(K)
- K963464RESTRAINT NET1Cleared 510(K)
- K963492PROTECTIVE RESTRAINT1Cleared 510(K)
- K963490PROTECTIVE RESTRAINT - BELTS1Cleared 510(K)
- K963477PEDIATRIC MITTENS1Cleared 510(K)
- K963387DELUXE LIMB RESTRAINT WITH DOUBLE D-RING AND STRAP DELUXE LIMB RESTRAINT WITH STRAP1Cleared 510(K)
- K963370CINCH STRAP WITH BUCKLE1Cleared 510(K)
- K963374TORSO/WAIST RESTRAINT1Cleared 510(K)
- K963371BEST STRAP RESTRAINT1Cleared 510(K)
- K963372HEELBO ER WRIST RESTRAINT1Cleared 510(K)
- K963494MORRISON MEDICAL DISPOSABLE RESTRAINT STRAP1Cleared 510(K)
- K963435ECONOMY SAFETY VEST RESTRAINT, SHOULDER TIE SAFETY VEST/SAFETY VEST RESTRAINT, HEAVY DUTY VEST RESTRAINT, MESH SAFETY VE1Cleared 510(K)
- K963431POLYESTER PIL WRIST/ANKLE RESTRAINT/WRIST RESTRAINT UNIVERSAL/SOFT FLANNEL WRIST/ANKLE RESTRAINT/FOAM LIMB HOLDER1Cleared 510(K)
- K963416ANKLE RESTRAINT SYSTEM1Cleared 510(K)
- K963399MORRISON MEDICAL STRETCHER/COT AND BACKBOARD RESTRAINTS1Cleared 510(K)
- K963138SPIDER STRAP1Cleared 510(K)
- K963060HEELBO SECURITY BELT1Cleared 510(K)
- K963199HEELBO PELVIC RESTRAINT1Cleared 510(K)
- K963099HEELBO PULLOVER PONCHO AND PULLOVER PONCHO WITH POCKET1Cleared 510(K)
- K963527UNIVERSAL ECONO-STRAP, QUALCRAFT UNIVERSAL STRAPS1Cleared 510(K)
- K963419MORRISON MEDICAL WRIST RESTRAINT1Cleared 510(K)
- K963393MESH VEST RESTRAINT WITH SLEEVES WRIST/ANKLE RESTRAINT1Cleared 510(K)
- K963041HEELBO LIFE JACKET WITH CROTCH SUPPORT1Cleared 510(K)
- K963528ALIMED POSITIONING 7 SAFETY STRAPS (THREE TYPES), UNIVERSAL CR/MRI WIDE BODY STRAP, UNIVERSAL CT SCANNER STRAP (2 SIZES)1Cleared 510(K)
- K963504MEDLINE OPEN END FINGER CONTROL MITT1Cleared 510(K)
- K963378MEDLINE ECONOMY LIMB HOLDER,DELUXE LIMB HOLDER,CINCH-TYPE LIMB HOLDER,PADDED LIMB HOLDER,ADJUSTABLE LIMB HOLDER1Cleared 510(K)
- K963526STRAP WEDGE1Cleared 510(K)
- K962963CHECKMATE ANKLE RESTRAINT SYSTEM1Cleared 510(K)
- K962964HEELBO JOHNNY GRAIT BELT SECURITY BELT1Cleared 510(K)
- K963569WHEELCHAIR WAIST BELT, MEDLINE ECONOMY WHEELCHAIR BELT, MEDLINE TWO-PIECE SAFETY SOFT BELT, MEDLINE WHEELCHAIR BELT WITH1Cleared 510(K)
- K963458PADDED MITTS/PADDED-PLUS MITTS/FINGER SEPARATOR PADDED MITTS/RIGID PALM PADDED MITTS1Cleared 510(K)
- K963452MEDLINE ZIPPER SLEEVED VEST1Cleared 510(K)
- K963404MEDLINE PELVIC HOLDER1Cleared 510(K)
- K963360MEDLINE BODY HOLDER1Cleared 510(K)
- K963362MEDLINE SAETY VEST,MEDLINE ECONOMY VEST, MEDLINE TIE-BACK VEST, MEDLINE SECURTIY VEST, VEST RESTRAINT1Cleared 510(K)
- K962839HEELBO QUILTED LIMB HOLDER WITH BUCKLE AND STRAP1Cleared 510(K)
- K962834HEELBO QUILTED LIMB HOLDER WITH DOUBLE D-RING, QUICK-RELEASE SNAP, AND STRAP1Cleared 510(K)
- K962832HEELBO QUILTED LIMB HOLDER WITH DOUBLE D-RING AND STRAP1Cleared 510(K)
- K962831THE INCH QUILTED LIMB HOLDER WITH QUICK RELEASE SNAP CLOSURE1Cleared 510(K)
- K963463STRAIT JACKET1Cleared 510(K)
- K963294HEELBO WRAP AROUND VEST1Cleared 510(K)
- K963460ROLL BELT1Cleared 510(K)
- K963457SLEEPER JACKET/HOUDINI SAFETY SLEEPER1Cleared 510(K)
- K963237HEELBO ICU 911 BLAZER SLEEVED JACKET1Cleared 510(K)
- K963108HEELBO QUILTED TORSO RESTRAINT1Cleared 510(K)
- K962810GREAT HANDS MITTS1Cleared 510(K)
- K962778THE L-BOW ARM RESTRAINT1Cleared 510(K)
- K963456LIMB HOLDERS-REUSABLE/LIMB HOLDERS-DISPOSABLE/QUICK-CUFF LIMB HOLDER1Cleared 510(K)
- K963448ECONO BELT1Cleared 510(K)
- K963454CUSHION BELT/CUSHION SLIDER BELT/ADJUSTA-LOOP CUSHION BELT/QUICK RELEASE CUSHION BELT1Cleared 510(K)
- K963450SAFETY VEST/SHOULDER STRAP VEST/ECONOMY SAFETY VEST1Cleared 510(K)
- K963449PELVIC HOLDER1Cleared 510(K)
- K963447DOUBLE SUPPORT PONCHO/SLIDER PONCHO1Cleared 510(K)
- K962626PATIENT PROTECTIVE LIMB1Cleared 510(K)
- K963243HEELBO BLAZER SLEEVED JACKET1Cleared 510(K)
- K962429SAFETY VEST1Cleared 510(K)
- K925924NEAL WRIST CONES1Cleared 510(K)
- K850470BED PRODUCTS1Cleared 510(K)
- K812473HEAD PROTECTOR1Cleared 510(K)
- K801272TECNOL QUICK RELEASE LIMB HOLDER1Cleared 510(K)
- K792012SKIL-CARE SUPER-SOFT LIMB RESTRAINTS1Cleared 510(K)
- K790699TECNOL BODY HOLDER1Cleared 510(K)
- K790172BK-5098 TILT TABLE STRAP1Cleared 510(K)
- K780232RESTRAINT, PROTECTIVE1Cleared 510(K)
- K771659PATIENT RESTRAINT SYSTEM1Cleared 510(K)
- K771630LIMB RESTRAINT1Cleared 510(K)
- K771636BODY RESTRAINT1Cleared 510(K)
- K771629HAND RESTRAINT1Cleared 510(K)
- K771715PELVIC WHEELCHAIR RESTRAINT1Cleared 510(K)
- K771635FOOT ELEVATOR1Cleared 510(K)
- K771634VEST RESTRAINT1Cleared 510(K)
- K771632FINGER MITT RESTRAINT1Cleared 510(K)
- K760618PATIENT RESTRAINT1Cleared 510(K)
- FMRDevice, Transfer, Patient, Manual1Product Code
- FMWCover, Mattress (Medical Purposes)1Product Code
- FNPUrinal1Product Code
- FNSRing Cutter1Product Code
- FNYBasin, Emesis1Product Code
- FOABoard, Cardiopulmonary1Product Code
- FOBBedpan1Product Code
- FOXStand, Infusion1Product Code
- FPFBottle, Hot/Cold Water1Product Code
- FPOStretcher, Wheeled2Product Code
- FPPStretcher, Hand-Carried1Product Code
- FPSBoard, Bed1Product Code
- FRAPurifier, Air, Ultraviolet, Medical2Product Code
- FRGWrap, Sterilization2Product Code
- FRJChair, Geriatric1Product Code
- FRKChair, Examination And Treatment1Product Code
- FRZDevice, Patient Transfer, Powered2Product Code
- GAZTubing, Noninvasive2Product Code
- GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered2Product Code
- JOKScissors, Medical, Disposable1Product Code
- JOLCatheter And Tip, Suction2Product Code
- KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories2Product Code
- KDPRegulator, Vacuum2Product Code
- KDQBottle, Collection, Vacuum2Product Code
- KIACover, Cast1Product Code
- KMEBedding, Disposable, Medical1Product Code
- KMGPurifier, Water, Ultraviolet, Medical2Product Code
- KMHSterilizer, Dry Heat2Product Code
- KMJLubricant, Patient1Product Code
- KMNChair And Table, Medical1Product Code
- KXFApplicator, Absorbent Tipped, Non-Sterile1Product Code
- KXGApplicator, Absorbent Tipped, Sterile1Product Code
- KYRBag, Ice1Product Code
- KYSInsoles, Medical1Product Code
- KYTLight, Examination, Medical, Battery Powered1Product Code
- KYWContainer, Liquid Medication, Graduated1Product Code
- KYXDispenser, Liquid Medication1Product Code
- KYZSyringe, Irrigating (Non Dental)1Product Code
- KZADevice, Vein Location, Liquid Crystal1Product Code
- KZFDevice, Medical Examination, Ac Powered1Product Code
- KZHIntroducer, Syringe Needle2Product Code
- LBJDevice, Vein Stabilization1Product Code
- LDSDevice, Pasteurization, Hot Water2Product Code
- LRJDisinfectant, Medical Devices1Product Code
- LYYLatex Patient Examination Glove1Product Code
- LYZVinyl Patient Examination Glove1Product Code
- LZAPolymer Patient Examination Glove1Product Code
- LZBFinger Cot1Product Code
- LZCPatient Examination Glove, Specialty1Product Code
- MDZCleaners, Medical Devices2Product Code
- MECDisinfector, Medical Devices2Product Code
- MEDSterilant, Medical Devices2Product Code
- MKBDevice, Germicidal, Ultraviolet2Product Code
- MLRSterilizer, Chemical2Product Code
- MMSLubricant, Vaginal, Patient1Product Code
- MTVSharps Needle Destruction Device2Product Code
- NRVImplantable Radio Frequency Transponder System2Product Code
- NZDStretcher, Patient Restraint1Product Code
- NZHMedication Management System, Remote2Product Code
- NZJRespirator, N95, For Use By The General Public In Public Health Medical Emergencies2Product Code
- OHYPill Crusher/Cutter1Product Code
- OIGPowder-Free Guayle Rubber Examination Glove1Product Code
- PEQAccessories To Examination Light1Product Code
- OPCPowder-Free Polychloroprene Patient Examination Glove1Product Code
- OPHRadiation Attenuating Medical Glove1Product Code
- OPIAntimicrobial Medical Glove1Product Code
- OPJMedical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs1Product Code
- ORWN95 Respirator With Antimicrobial/Antiviral Agent For Use By The General Public In Public Health Medical Emergencies2Product Code
- OSZAntimicrobial Keyboard2Product Code
- OUGMedical Device Data System1Product Code
- OVYLiquid Chemical Processing System2Product Code
- OYSPatient Bed With Canopy/Restraints1Product Code
- PADChest Drainage Kit2Product Code
- PECSterilizer Automated Loading System2Product Code
- PJJTwo Or More Sterilant Sterilizer2Product Code
- PWMAdmission Kit (Patient Utensil)1Product Code
- PYQRfid Chip For Dental Appliance2Product Code
- PWPBlood Borne Pathogen Response Kit1Product Code
- PWSChemotherapy Administration Kit1Product Code
- PWTChemotherapy Spill Clean-Up Kit1Product Code
- PWUClean-Up Kit1Product Code
- PWVDelivery Room Apparel Kit1Product Code
- PWZMid-Stream Collection Kit1Product Code
- PXAOral Administration Set1Product Code
- PXCPersonal Protection Kit1Product Code
- PXDPrep Kit1Product Code
- PXFSitz Bath Kit1Product Code
- PXGSpill Kit1Product Code
- PXMVomitus Clean-Up Kit1Product Code
- QDOFentanyl And Other Opioid Protection Glove1Product Code
- QTVMattress And Bed Deck Cover (Medical Purposes)1Product Code
- 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
FULL BODY RESTRAINT SYSTEM
- Page Type
- Cleared 510(K)
- 510(k) Number
- K972046
- 510(k) Type
- Traditional
- Applicant
- GILLEN INDUSTRIES
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/15/1997
- Days to Decision
- 74 days
- Submission Type
- Statement