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
- K120783ABLE-X1Cleared 510(K)
- K885343STANDEX1Cleared 510(K)
- K851065GRAVITY KING (DEEMED SE 87/09/18)1Cleared 510(K)
- K840551MOBILIZER1Cleared 510(K)
- K833870KNEE WALKER1Cleared 510(K)
- K833249FITNESS1Cleared 510(K)
- K832968PEDAL EXERCISER1Cleared 510(K)
- K831543ADJUST. WEIGHTS-BK5171-05,10,20 BEOK1Cleared 510(K)
- K831538DELUXE ADJUST-ANGLE BOARD-BK40661Cleared 510(K)
- K831033GIREX1Cleared 510(K)
- K830560EXERCISER, PASSIVE, NON MEASURING1Cleared 510(K)
- K830400MADDATRAINER HAND EXERCISER1Cleared 510(K)
- K823236BACK ON TRACK INVERSION THERAPY & EXER1Cleared 510(K)
- K823623INFLATABLE HEAVY PLASTIC EXERCISER1Cleared 510(K)
- K823620PLASTIC ELASTOMER IN CUBE FORM EXERCISE1Cleared 510(K)
- K823619PLASTIC ELASTOMER ENCASED IN TERRY CLOTH1Cleared 510(K)
- K823618PROGRESSIVE RESISTANCE EXERCISE CUFF1Cleared 510(K)
- K822906PHYSICAL MEDICINE & REHABILITATION EQUIP1Cleared 510(K)
- K821857BK-5305 MULTIPLE HAND GRID1Cleared 510(K)
- K821855VISCO HANDEX-VARIOUS MODELS1Cleared 510(K)
- K813633MODELING COMPOUND AND FOAM EXERCISER1Cleared 510(K)
- K813099BACK RIE1Cleared 510(K)
- K812474BABY WALKER W/TOY CHEST1Cleared 510(K)
- K812351NON-MEASURING EXERCISERS1Cleared 510(K)
- K810444NON-MEASURING EXERCISERS1Cleared 510(K)
- K801710BK-5315-01 FOAM HAND EXERCISER, SMALL1Cleared 510(K)
- K801453FINGER, HAND & WRIST EXERCISER1Cleared 510(K)
- K792642THE VARIABLE LOAD KENETIC ENERGIZER1Cleared 510(K)
- K800017COLOR CODED PUTTY SOFT, REGULAR & FIRM1Cleared 510(K)
- K790572LOUNGE, TILT-A-BODY STRETCH1Cleared 510(K)
- K790530PUSH BALL INCLINE1Cleared 510(K)
- K790191VISA-GRIP1Cleared 510(K)
- K781350OBJECTS PRECISION HANDLING TEST KIT1Cleared 510(K)
- K772404FINGER EXERCISE BOARD1Cleared 510(K)
- K770658EXERCISER, LEG, LOWER EXTREMITY1Cleared 510(K)
- K770436EXERCISER, EXTENSOR WAND1Cleared 510(K)
- K770144RHEUMATOID HAND GYM1Cleared 510(K)
- K761314FLEXION-BRAKING KNEE-SHIN ASSEMBLY1Cleared 510(K)
- K7613134-BAR KNEE-SHIN SET-UP1Cleared 510(K)
- K761135SHORT INFLATED ROLLS1Cleared 510(K)
- K761120SPIN-A-PULL1Cleared 510(K)
- K760305BALLOONS, BK-8112, 81141Cleared 510(K)
- K760304CANOPY, PARACHUTE, BK-81101Cleared 510(K)
- 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
- 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
PLASTIC ELASTOMER ENCASED IN TERRY CLOTH
- Page Type
- Cleared 510(K)
- 510(k) Number
- K823619
- 510(k) Type
- Traditional
- Applicant
- FRED SAMMONS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/22/1982
- Days to Decision
- 16 days