Anesthesiology
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- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
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- MiscellaneousMiscellaneous
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- MOCCushion, Flotation, Therapeutic2Product Code
- IMGStimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat2Product Code
- IMIUltrasonic Diathermy For Use In Applying Therapeutic Deep Heat2Product Code
- IMJDiathermy, Shortwave, For Use In Applying Therapeutic Deep Heat2Product Code
- QOLElectroencephalography (Eeg)-Driven Upper Extremity Powered Exerciser2Product Code
- QRAVirtual Reality Behavioral Therapy Device For Pain Relief2Product Code
- BXBExerciser, Powered1Product Code
- EGJDevice, Iontophoresis, Other Uses2Product Code
- HPHDiathermy, Microwave, For Use Other Than Applying Therapeutic Deep Heat3Product Code
- IKWUtensil, Homemaking1Product Code
- IKXAid, Transfer1Product Code
- IKZBed, Patient Rotation, Powered2Product Code
- ILCUtensil, Eating1Product Code
- ILDAdaptor, Dressing1Product Code
- ILJBath, Hydro-Massage2Product Code
- ILKTransport, Patient, Powered2Product Code
- ILMBath, Sitz, Powered2Product Code
- ILOPack, Hot Or Cold, Water Circulating2Product Code
- ILSAdaptor, Hygiene1Product Code
- ILTAdaptor, Recreational1Product Code
- ILWAdaptor, Grooming1Product Code
- ILXDiathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat2Product Code
- ILYLamp, Infrared, Therapeutic Heating2Product Code
- ILZAccessories, Traction1Product Code
- IMAPack, Heat, Moist1Product Code
- IMBCabinet, Moist Steam2Product Code
- IMCBath, Paraffin2Product Code
- IMDPack, Hot Or Cold, Disposable1Product Code
- IMEPack, Hot Or Cold, Reusable1Product Code
- IMFUnit, Chilling1Product Code
- INXBed, Air Fluidized2Product Code
- INYBed, Patient Rotation, Manual1Product Code
- IOADiathermy, Microwave, For Use In Applying Therapeutic Deep Heat2Product Code
- IOBLamp, Infrared, Non Heating2Product Code
- IODComponents, Exercise1Product Code
- IOEBars, Parallel, Exercise1Product Code
- IOGTreadmill, Mechanical1Product Code
- IOLTreadmill, Powered1Product Code
- IONExerciser, Non-Measuring1Product Code
- IOQBed, Flotation Therapy, Powered2Product Code
- IPFStimulator, Muscle, Powered2Product Code
- IRNDevice, Warning, Overload, External Limb, Powered2Product Code
- IROVibrator, Therapeutic1Product Code
- IRPMassager, Powered Inflatable Tube2Product Code
- K242140Air Compression Leg Massager (K-705)2Cleared 510(K)
- K243206Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4, ACM-PLUS-A5, ACM-PLUS-A6)2Cleared 510(K)
- K243572Game Ready system (550500-04); Game Ready Control Unit (550550-04); Game Ready Full Leg Boot Wrap - Medium (590923-04); Game Ready Full Leg Boot Wrap - Large (590922-04); Game Ready C-T Spine Wrap (590502-04); Game Ready Half Leg Boot (590906-04); Game Ready Back Wrap (590500-04); Game Ready Hand/Wrist Wrap (590811-04); Game Ready Flexed Elbow Wrap (590903-04); Game Ready Straight Elbow Wrap (590200-04); Game Ready Shoulder Wrap, Medium, Right (590422-04); Game Ready Shoulder Wrap, La2Cleared 510(K)
- K243791Air Pressure Therapy System2Cleared 510(K)
- K243177SACS PRO2Cleared 510(K)
- K232965Leg Massager (Models:RP-ALM070H, RP-ALM071H)2Cleared 510(K)
- K243320Air Pressure Therapy System (VU-IPC04B)2Cleared 510(K)
- K242940Xrecovery (XR-001)2Cleared 510(K)
- K241446Air Compression Massager (ACM-A1, ACM-A2, ACM-A3, ACM-A4)2Cleared 510(K)
- K240373Air compression Leg Massager (MM0520, MM0521, MM0522)2Cleared 510(K)
- K241256JetBoots PRO Plus2Cleared 510(K)
- K240981Air compression leg massager2Cleared 510(K)
- K233238Air Pressure Therapy System (Model:VU-IPC4M)2Cleared 510(K)
- K240986Cold Compression2Cleared 510(K)
- K240122Normatec Elite2Cleared 510(K)
- K230524Cold Compression Wrap Pro2Cleared 510(K)
- K223729FLOWpresso2Cleared 510(K)
- K233536Air Compression Recovery System2Cleared 510(K)
- K223541Cold/Hot Compression2Cleared 510(K)
- K230500Air Compression Therapy Recovery System (model: MF-AWI, MF-AWI.LED.A-801, MF-AWI.LED.B-801, MF-AWI.OLED.A-601, MF-AWI.LED.A-601, MF-AWI.LED.B-601, MF-AWI.OLED.A-401, MF-AWI.LED.A-401, MF-AWI.LED.B-401)2Cleared 510(K)
- K231912Therm-X2Cleared 510(K)
- K231437LF9002Cleared 510(K)
- K230385Ballancer Platinum (1222)2Cleared 510(K)
- K222991Air Compression Leg Massager (model: EMK-701)2Cleared 510(K)
- K223464Leg and Foot Air Wave Pressure Therapy Device2Cleared 510(K)
- K222136Cryo-Thermo Compression Device (FGK002)2Cleared 510(K)
- K222924Leg Massager RF-ALM0702Cleared 510(K)
- K222949Air Compression Leg Massager (Model: LY-670D)2Cleared 510(K)
- K221862YY-A02-B Overlapped Compression Therapy2Cleared 510(K)
- K222669Cryopush Cold Compression Device2Cleared 510(K)
- K223164Aquilo Sports CCT1500 System2Cleared 510(K)
- K222206Air Compression Leg Massager (Models: S9036C, S9036B and S9036A)2Cleared 510(K)
- K201730Powered Inflatable Tube Massager - SLIM UP DRAIN2Cleared 510(K)
- K221666Normatec Go2Cleared 510(K)
- K213745Air Compression Therapy Device, model: ST-5022Cleared 510(K)
- K211850Air Compression Leg Massager (model: FE-7204B)2Cleared 510(K)
- K220217Normatec 32Cleared 510(K)
- K212935Air Pressure Foot Massager2Cleared 510(K)
- K213533Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL2Cleared 510(K)
- K212713Air compression leg massager HY-1117A2Cleared 510(K)
- K212169Air compression therapy system FO30022Cleared 510(K)
- K213000Air Compression Massager (Model LF-FT003)2Cleared 510(K)
- K211745RecoveryAir PRO2Cleared 510(K)
- K211283Compressible Limb and Circulation Therapy System, Model POWER-Q23002Cleared 510(K)
- K212491Air Relax Pro Model AR-4.02Cleared 510(K)
- K202395SP-1000, SP-20002Cleared 510(K)
- K210913V12 PRO2Cleared 510(K)
- K203498LX9max2Cleared 510(K)
- K203019LF9002Cleared 510(K)
- K201935Air Pressure Therapy System2Cleared 510(K)
- K210281Fist Assist Devices Model FA-12Cleared 510(K)
- K211460Air Relax Plus Model AR-3.02Cleared 510(K)
- K210967Air Pressure Therapy System: VU-IPC062Cleared 510(K)
- K201982Air compression therapy system FO-3001; Air compression therapy system FO-30082Cleared 510(K)
- K200660Compressible Limb and Circulation Therapy System2Cleared 510(K)
- K202693NeoWave Pain Relief and Recovery System, Model# T16-20202Cleared 510(K)
- K191441Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0)2Cleared 510(K)
- K210240Air Compression Therapy Device, model HW60072Cleared 510(K)
- K193079ICE COMPRESSION FIRST, DUO, & MOOVE Systems2Cleared 510(K)
- K203552Rapid Reboot2Cleared 510(K)
- K201694Air Compression Therapy Device2Cleared 510(K)
- K202044Powerpress Recovery Unit2Cleared 510(K)
- K201645Massage Compression Boots2Cleared 510(K)
- K200351PlasmaFlight2Cleared 510(K)
- K192466Air Compression Therapy System2Cleared 510(K)
- K193354Air Compression Therapy Device2Cleared 510(K)
- K192358Pressure Therapy System PT10032Cleared 510(K)
- K193550Therm-X2Cleared 510(K)
- K192607LiteWalk2Cleared 510(K)
- K192114Game Ready GRPro 2.1 System2Cleared 510(K)
- K191862Compression Therapy Device Model LGT-2200SP2Cleared 510(K)
- K192252ProPerformance Recovery System2Cleared 510(K)
- K173158Air Relax2Cleared 510(K)
- K190493Recovery Pump, 737R (RPX)2Cleared 510(K)
- K190854Therm-X2Cleared 510(K)
- K190015Ballancer Gold, 12122Cleared 510(K)
- K183702Polar Care Wave2Cleared 510(K)
- K181409Pressure Therapy System PT10032Cleared 510(K)
- K183169Pulse 2.0, Pulse Pro 2.02Cleared 510(K)
- K182668Rapid Reboot Compression Therapy System2Cleared 510(K)
- K181149Therm-X Pro, Therm-X AT, Therm-X Pro Athlete2Cleared 510(K)
- K171685Med4 Elite2Cleared 510(K)
- K161907Pressure Therapy System2Cleared 510(K)
- K163280RP Lite 760R2Cleared 510(K)
- K160178Lympha-Flow(LF1200)2Cleared 510(K)
- K160608NormaTec Pulse and NormaTec Pulse Pro2Cleared 510(K)
- K150269Ballancer 505 System, Model 1201-AC2Cleared 510(K)
- K150033Air Compressible Limb Therapy System2Cleared 510(K)
- K143197Nice12Cleared 510(K)
- K140519RECOVERY PUMP 737R2Cleared 510(K)
- K133483PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK FOR OTC USE2Cleared 510(K)
- K130385COMPRESSIBLE LIMB SLEEVE SYSTEM2Cleared 510(K)
- K1221122004-OC MASSAGE SYSTEM, 2008-OC MASSAGE SYSTEM2Cleared 510(K)
- K123829PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK2Cleared 510(K)
- K122154POWERPLAY MUSCLE MASSAGER2Cleared 510(K)
- K120166COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM2Cleared 510(K)
- K113275COMPRESSIBLE LIMB THERAPY SYSTEM2Cleared 510(K)
- K112441COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM2Cleared 510(K)
- K112890NORMATEC MVP2Cleared 510(K)
- K112479DSJ MASSAGER2Cleared 510(K)
- K102320COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM MODEL LX7(V7)2Cleared 510(K)
- K102319COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM MODEL WIC-20082Cleared 510(K)
- K100656COMPRESSIBLE LIMB THERAPY SYSTEM MODEL WHF-324 (POWER-Q1000 PLUS)2Cleared 510(K)
- K092435VERSEO AIR PRESSURE MASSAGER2Cleared 510(K)
- K080134COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM, MODEL WHF-314 (POWER-Q1000)2Cleared 510(K)
- K071596POTABLE AIR MASSAGER PUTIFINO, MODEL AM-72Cleared 510(K)
- K072620GAME READY CLASSIC SYSTEM, MODEL 5505502Cleared 510(K)
- K071050GAME READY PROFESSIONAL THERAPY SYSTEM, MODEL 550100, GAME READY PRE-PROGRAMMED PROFESSIONAL THERAPY SYSTEM2Cleared 510(K)
- K040905WELLNESS/JOLIVETE2Cleared 510(K)
- K032505AIR PRESS MASSAGER2Cleared 510(K)
- K030437RELAXOR PERFECT TOUCH AIR MASSAGING SYSTEM2Cleared 510(K)
- K013061BIOTOUCH MASSAGE THERAPY SYSTEM2Cleared 510(K)
- K003909PROACT 12Cleared 510(K)
- K000655PPCID- PNEUMATIC PERIPHERAL CIRCULATION IMPROVEMENT (FOOTREST) DEVICE2Cleared 510(K)
- K994057SLENDAIR 4000 COMPRESSION SYSTEM2Cleared 510(K)
- K991921INTERMITTENT COMPRESSION BOOT FOR OTC2Cleared 510(K)
- K974395ATLANT'S2Cleared 510(K)
- K964957INTERMITTENT COMPRESSOR SYSTEM2Cleared 510(K)
- K961426BIO BOOST2Cleared 510(K)
- K953516MEDCOMP MC 5 GRADIENT SEQUENTIAL PUMP2Cleared 510(K)
- K951769CRYOPRESS2Cleared 510(K)
- K915638TALLEY TM200 INTERMTTENT COMPRESSION UNIT2Cleared 510(K)
- K915637TALLEY TM500 SEQUENTIAL MULTICOM COMPRESSION SYST.2Cleared 510(K)
- K915092TALLEY TM300 SEQUENTIAL MULTICOM COMPRESSION SYST2Cleared 510(K)
- K914774MULTIPULSE SEQUENTIAL COMPRESSION UNIT2Cleared 510(K)
- K914142HEMO-PULSE 20002Cleared 510(K)
- K912004SHEPARD CRYOPRESS/CAMP MULTI-TEMP SPORT PUMPS2Cleared 510(K)
- K901022POWERED INFLATABLE TUBE MASSAGER, SPORT-MED2Cleared 510(K)
- K893950VENTIPRESS 24 AND 14 PRESSURE VENTILATOR2Cleared 510(K)
- K874688FLOWTRON AC200/22Cleared 510(K)
- K860632EBI HAND MASSAGING PUMP (HMP)2Cleared 510(K)
- K852264EBI FOOT MASSAGING PUMP2Cleared 510(K)
- K834507HYDROPULSE(GROSSAN);INFLAT TUBE MASS2Cleared 510(K)
- K832920INTERMITTENT COMPRESSION PUMPS2Cleared 510(K)
- K821920I.C.E. BOX2Cleared 510(K)
- K781964COMPRESSION DEVICES, LIMB2Cleared 510(K)
- K780710AIR MASSAGE SYSTEM2Cleared 510(K)
- IRQUnit, Heating, Powered1Product Code
- IRRBars, Parallel, Powered1Product Code
- IRSHead Halter, Traction1Product Code
- IRTPad, Heating, Powered2Product Code
- ISAMassager, Therapeutic, Electric1Product Code
- ISDExerciser, Measuring2Product Code
- ITHEquipment, Traction, Powered2Product Code
- JFAExerciser, Finger, Powered1Product Code
- JFBTable, Physical Therapy, Multi Function2Product Code
- KNLBoard, Scooter, Prone1Product Code
- KNMDevice, Pressure Applying1Product Code
- KTBDevice, Iontophoresis, Specific Uses2Product Code
- KTCBath, Sitz, Nonpowered1Product Code
- LBGDevice, Fluidized Therapy, Dry Heat2Product Code
- LSBUnit, Fluidotherapy2Product Code
- LXFDiathermy, Ultrasonic, For Use Other Than Applying Therapeutic Deep Heat3Product Code
- LXJInteractive Rehabilitation Exercise Devices2Product Code
- LYGMassager, Therapeutic, Manual1Product Code
- MPOInfant Heel Warmer (Chemical Heat Pack)1Product Code
- NGXStimulator, Muscle, Powered, For Muscle Conditioning2Product Code
- NHNPowered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy2Product Code
- NYYStimulator, Muscle, Powered, With Limited Output, For Rehabilitation2Product Code
- NYZStimulator, Muscle, Powered, With Limited Output, For Muscle Conditioning2Product Code
- OMWAdhesive Backed Thermal Skin Patches1Product Code
- OSDMassager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature2Product Code
- PCDPowered Stairway Chair Lift2Product Code
- PFWStationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat2Product Code
- PHWCold Pack And Vibrating Massager1Product Code
- PKSExerciser, Non-Measuring For Stroke Rehabilitation1Product Code
- PQYNonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain2Product Code
- QKCInteractive Rehabilitation Exercise Device, Prescription Use2Product Code
- QKDMassager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature, Prescription Use2Product Code
- QTCAdult Portable Bed Rails For Medical Purposes1Product Code
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
Normatec Elite
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K240122
- 510(k) Type
- Traditional
- Applicant
- NormaTec Industries, LP
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/21/2024
- Days to Decision
- 65 days
- Submission Type
- Summary