Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- 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
- IRQUnit, Heating, Powered1Product Code
- IRRBars, Parallel, Powered1Product Code
- IRSHead Halter, Traction1Product Code
- IRTPad, Heating, Powered2Product Code
- ISAMassager, Therapeutic, Electric1Product Code
- K243488VMAT PRO1Cleared 510(K)
- K240358ShockPhysio Mobile (model SW3200 Basic)1Cleared 510(K)
- K221865BTL-0941Cleared 510(K)
- K210166Omnispec ED10001Cleared 510(K)
- K213120OW100S (model OW100S-US)1Cleared 510(K)
- K220538DolorClast Radial1Cleared 510(K)
- K210451OrthoGold 1001Cleared 510(K)
- K182682OrthoGold 1001Cleared 510(K)
- K173692D-Actor 200 Vibration Massage System1Cleared 510(K)
- K053225CELLU M6 KEYMODULE I1Cleared 510(K)
- K030876CYNOSURE TRIACTIVE THERAPEUTIC MASSAGE SYSTEM1Cleared 510(K)
- K002908JET THERAPY1Cleared 510(K)
- K990445LPG THERAPEUTIC MASSAGER, MODELS -ESI, THERAPEUTIC MASSAGER/VIBRATOR1Cleared 510(K)
- K952990SPIN ROLLERE1Cleared 510(K)
- K952041BODYFLEX MASSAGER1Cleared 510(K)
- K950411RELAXU-11Cleared 510(K)
- K950931AVON MASSAGING HAIRBRUSH1Cleared 510(K)
- K950655THERMO MASSAGE UNIT, ELEC. THERAPUTIC MASSAGES1Cleared 510(K)
- K950321SHAPE UP MOMI ROLLER1Cleared 510(K)
- K950322RELAXY-THE WONDER HAND1Cleared 510(K)
- K950320RELAXY-WONDER KNOCK1Cleared 510(K)
- K944884DR-3, DR-6, DR-68, DR-88, AMR-6, FR-22R, DR-22B1Cleared 510(K)
- K944885DH-1, DH-2, DH-3, DH-6, DH-68, DH-8, AMH-6, FM-10, FM-20, FM-30, FBM-1000, FBM-20001Cleared 510(K)
- K944730MASSAGER1Cleared 510(K)
- K936178AGILANCE-GOLDEN SPOONS1Cleared 510(K)
- K944637FAMILY FITNESS SHIATSU MASSAGER1Cleared 510(K)
- K944024STIMU-TAP1Cleared 510(K)
- K943092FAMILY FITNESS SHIATSU MASSAGER1Cleared 510(K)
- K942950BODY FLEX1Cleared 510(K)
- K942218SHIATSU MASSAGER1Cleared 510(K)
- K940621PRO-SHIATSU PORTABLE MASSAGER1Cleared 510(K)
- K942223BODY SYSTEM1Cleared 510(K)
- K941594WAHL DOUBLE COMFORT MASSAGER1Cleared 510(K)
- K940683WAHL(R) ULTRA COMFORT MASSAGER SPEC #89ISA1Cleared 510(K)
- K940543MODEL 777 THERAPEUTIC MASSAGER1Cleared 510(K)
- K940369BODY RECHARGER1Cleared 510(K)
- K925907AQUASSAGER WM110/W210 & WM120 BODY BASICS MASSAGER1Cleared 510(K)
- K931636FO18/FO98 SCRUBOFLEX SHOWERPROOF BRUSH MASSAGER1Cleared 510(K)
- K935581OMRON MASSAGER MODEL HM-1021Cleared 510(K)
- K935459OMRON MASSAGER MODEL HM-451Cleared 510(K)
- K935462OMBRON TWIN-HEAD MASSAGER MODEL HM-1011Cleared 510(K)
- K926339BODY RELAXER1Cleared 510(K)
- K911727INFRADERM; TOUCH 'N TONE PLUS1Cleared 510(K)
- K932904WINDMERE WAND MASSAGER1Cleared 510(K)
- K924237WINDMERE PRELUDE III1Cleared 510(K)
- K924518BODY SOOTHER1Cleared 510(K)
- K924520BODY TRAINER1Cleared 510(K)
- K925036HANDY VIBRO BELT1Cleared 510(K)
- K923541BODY-MATE MASSAGER1Cleared 510(K)
- K921000SONACARE SOUND MASSAGER1Cleared 510(K)
- K915729AUQASOOTHE/AQUA MED1Cleared 510(K)
- K914943AQUA MED1Cleared 510(K)
- K912822PERSONAL BODY MASSAGER, MODELS 1605 & 16061Cleared 510(K)
- K912383VIBRATOUCH II CORDLESS WAND MASSAGER1Cleared 510(K)
- K912634CORDLESS ELECTRIC MASSAGER EV3151Cleared 510(K)
- K910519GOOD VIBRATIONS TUBE MASSAGER1Cleared 510(K)
- K904915CARESS MASSAGER1Cleared 510(K)
- K903617MUSCLE MASSAGER1Cleared 510(K)
- K904242QI-GONG MACHINE THERAPEUTIC MASSAGER1Cleared 510(K)
- K901796PODOFLEX EXERCISER-PASSIVE-FOOT/ANKLE1Cleared 510(K)
- K900674CONSTI-SSAGE VIBRATOR/MASSAGE1Cleared 510(K)
- K893029OMRON TRAVEL MASSAGER, MODEL HM-011Cleared 510(K)
- K892669COMFORTRAC, CT90 & CT100 BI-PHASICS1Cleared 510(K)
- K891871PHASER (SINGLE LINEAR MECHANICAL MASSAGE)1Cleared 510(K)
- K891394PM830 ELECTRIC MASSAGER1Cleared 510(K)
- K890923VITALON MATRESS MASSAGE MODEL M-MX1Cleared 510(K)
- K890643VITALON CHAIR MASSAGER MODEL V-CHR21Cleared 510(K)
- K883064MASSAGE MACHINE (CAT. EM-01 ULE 111756)1Cleared 510(K)
- K874716PULSOR, THERAPEUTIC VIBRATOR1Cleared 510(K)
- K873819MODIFIED STRESS MACHINE1Cleared 510(K)
- K874843VITALON MASSAGER1Cleared 510(K)
- K873794HOT ROD THERMAL MASSAGE ROLLER1Cleared 510(K)
- K872028BIRDIE BRACKET1Cleared 510(K)
- K870939VIBRACARE1Cleared 510(K)
- K864088HITACHI HAND HELD MASSAGER A/C POWERED1Cleared 510(K)
- K863197VIBROFLEX1Cleared 510(K)
- K863383FACIAL MASSAGER, BATTERY POWERED1Cleared 510(K)
- K862041WM10, WM20, WM30 POWER MASSAGER1Cleared 510(K)
- K861834THERACUSHION MODEL 10001Cleared 510(K)
- K853710THERACUSHION1Cleared 510(K)
- K853297MULTIPLE1Cleared 510(K)
- K852944FLEXIMATIC MASSAGER1Cleared 510(K)
- K850851G5 APPARATUS T, K1, K3 & THE PRESIDENT MODEL'S1Cleared 510(K)
- K850771OSTER MASSAGE WAND STICK MASSAGER 295-071Cleared 510(K)
- K842802VACOMED 41Cleared 510(K)
- K840035HAYDAY IRRIT-EASER WAND1Cleared 510(K)
- K833840MASSATOR-PEDIO1Cleared 510(K)
- K832913BACK MASSAGER B-400 ADJUSTABLE1Cleared 510(K)
- K833090SENSORY ROLLER MASSAGER1Cleared 510(K)
- K831699STRESS MACHINE1Cleared 510(K)
- K831206ARUBI FLATTER & ARUBI FLATTER-S1Cleared 510(K)
- K823927HIPUSH HANDHELD MASSAGER1Cleared 510(K)
- K821109TRIMMORE ELECTION BEAUTIFIER1Cleared 510(K)
- K811782SOFT & STROKE1Cleared 510(K)
- K811891NORELCO MASSAGER PLUS HEAT BELT1Cleared 510(K)
- K810447MAGIC CUSHION MASSAGER1Cleared 510(K)
- K810354PERCUSS-O-FLEX FOOT & HAND MASSAGER1Cleared 510(K)
- K801593LEBODY BY WATER PIK1Cleared 510(K)
- K780683TISSUE PULSATOR1Cleared 510(K)
- K760616PROPIOCEPTOR MASSAGER1Cleared 510(K)
- 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
DR-3, DR-6, DR-68, DR-88, AMR-6, FR-22R, DR-22B
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K944884
- 510(k) Type
- Traditional
- Applicant
- KOLVIN INDUSTRIES LTD.
- Country
- Hong Kong SAR China
- FDA Decision
- Substantially Equivalent for Some Indications
- Decision Date
- 2/14/1995
- Days to Decision
- 134 days
- Submission Type
- Statement