Anesthesiology
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- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview 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
- K955250QI GONG MASSAGER1Cleared 510(K)
- K955160COMFORT, MUSCLE, CORDLESS MASSAGER, BATTERY POWERED OPERATED MASSAGER1Cleared 510(K)
- K954203MASSAGER THERAPUTIC, ELECTRIC1Cleared 510(K)
- K952916SHIATSU MASTER MASSAGER CUSHION1Cleared 510(K)
- K951414CHAMPION PHYSIOACOUSTICC RECLINER-TRANSPORTER CHAIR1Cleared 510(K)
- K950441CONAIR FAMILY FITNESS BODY ENERGY1Cleared 510(K)
- K946382SKALPI 32001Cleared 510(K)
- K950410CONAIR BODY AND SOLE1Cleared 510(K)
- K944909WAHL FRESH FACE1Cleared 510(K)
- K950400HAND MASSAGE UNIT1Cleared 510(K)
- K945603CORDLESS MASSAGER WITH HEAT ( VARIOUS BRAND NAMES)1Cleared 510(K)
- K940582MASSAGING HELMET C.F. HANSEN DESIGN1Cleared 510(K)
- K943730SQUEEZE PLAY1Cleared 510(K)
- K941412WAHL COMPACT COMFORT MASSAGER1Cleared 510(K)
- K940837WAHL(R) FOOT COMFORT MASSAGER1Cleared 510(K)
- K934886NEXT WAVE PHYSIOACOUSTIC MATTRESS1Cleared 510(K)
- K931638FO96 HANDY MASSAGER1Cleared 510(K)
- K931637A013 FEMI-FORM FACIAL MASSAGER1Cleared 510(K)
- K931640AO11 BODY MASSAGER1Cleared 510(K)
- K931639F183 AC-MINI MASSAGER WITH UL APROVED ADAPTOR1Cleared 510(K)
- K933974WINDMERE MASSAGE MATE1Cleared 510(K)
- K923238SONASSAGE1Cleared 510(K)
- K931819CARAPACE SUTURE REMOVAL TRAYS1Cleared 510(K)
- K924581HEALTH ESSENTIALS MAXI MASSAGER1Cleared 510(K)
- K924583HEALTH ESSENTIALS MULTI-PURPOSE MASSAGER1Cleared 510(K)
- K924582HEALTH ESSENTIALS BODY CARE MASSAGER1Cleared 510(K)
- K924584HEALTH ESSENTIALS FANCY PERSONAL MASSAGER1Cleared 510(K)
- K924519BODYTHERM1Cleared 510(K)
- K924431HEALTLH ESSENTIALS PERSONAL MASSAGER1Cleared 510(K)
- K931086WINDMERE VIBRA TOUCH PERSONAL BODY MASSAGER1Cleared 510(K)
- K920487MINI VIBRATOR1Cleared 510(K)
- K913439SONIX...THERAPEUTIC SONIC MASSAGE1Cleared 510(K)
- K913998PAM PLUS1Cleared 510(K)
- K915242TOUCH N TONE 1 MASSAGER1Cleared 510(K)
- K914830A101 LITESSAGER1Cleared 510(K)
- K914829FO92 SEATING MASSAGER1Cleared 510(K)
- K914705FO41 BODY MASSAGER1Cleared 510(K)
- K914703F383 RECHARGEABLE MINI MASSAGER1Cleared 510(K)
- K914704FO69 FANCY MASSAGER1Cleared 510(K)
- K914706FO51/F151 GOLF MASSAGER1Cleared 510(K)
- K914707F055 B.O. FANTASTIC RELAXER1Cleared 510(K)
- K914344MULTI-REACH II WAND MASSAGER1Cleared 510(K)
- K912659SOUND RELIEF1Cleared 510(K)
- K912479MOTOR MASSAGE PILLOW1Cleared 510(K)
- K905836ULTRA WAVE 1011Cleared 510(K)
- K903098MINI-VIBRATOR1Cleared 510(K)
- K901931LEG EEZE1Cleared 510(K)
- K896947CHIROPRACTIC MASSAGE PILLOW1Cleared 510(K)
- K883913LA MASSEUSE1Cleared 510(K)
- K871107VASOTRAIN 4471Cleared 510(K)
- K870972SONAFON, THERAPEUTIC MASSAGER1Cleared 510(K)
- K860159THUMPER (VIBRATOR/MASSAGER)1Cleared 510(K)
- K850495AKUFON THERAPEUTIC MASSAGER1Cleared 510(K)
- K842379ELECTRO-SAGE MODEL 2031Cleared 510(K)
- K833370LINEAR VIBRATION A MCSHIRLEY PRODUCT1Cleared 510(K)
- K830715NORELCO VIBRATING BOARD V9001Cleared 510(K)
- K821133ELECTRICAL VIBRATING DEVICE1Cleared 510(K)
- K821633VARIABLE SPEED VIBRATOR, 120V 83-117 VIB1Cleared 510(K)
- K812902ACUPRESS VIBRATOR1Cleared 510(K)
- K810446VIBRATOR1Cleared 510(K)
- K810244PORTA-PULS MUSCLE STIMULATOR1Cleared 510(K)
- K800250HMB-2001Cleared 510(K)
- K800018BK-5203 FACILITATION VIBRATOR ELECTRIC1Cleared 510(K)
- K771279HEAD FACILITATION VIBRATOR BK-52101Cleared 510(K)
- K761121ELECTRIC VIBRATOR1Cleared 510(K)
- IRPMassager, Powered Inflatable Tube2Product Code
- 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
- SGTElectromagnetic Stimulator For Healthy Muscle Stimulation2Product Code
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
MASSAGING HELMET C.F. HANSEN DESIGN
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K940582
- 510(k) Type
- Traditional
- Applicant
- PHILCO USHUAIA
- Country
- Canada
- FDA Decision
- Substantially Equivalent for Some Indications
- Decision Date
- 1/30/1995
- Days to Decision
- 356 days
- Submission Type
- Statement