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Physical Medicine devices

187 product codes reviewed by the Physical Medicine panel. 5,674 510(k) clearances and 770 recalls in the FDA data, 35% of those recalls name a 510(k).

136510(k)s in 12 months
50recalls in 12 months
269recalls that name a 510(k)

Active product codes, Class II

CodeDeviceClass510(k)s, 12 moRecalls, 12 mo
ITIWheelchair, Powered24317
INIVehicle, Motorized 3-Wheeled2240
IRPMassager, Powered Inflatable Tube2130
OAPLaser, Comb, Hair2110
ILJBath, Hydro-Massage2010
NGXStimulator, Muscle, Powered, For Muscle Conditioning260
ILOPack, Hot Or Cold, Water Circulating204
ILYLamp, Infrared, Therapeutic Heating212
IOQBed, Flotation Therapy, Powered203
IPFStimulator, Muscle, Powered230
NHNPowered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy230
SDOTranscutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation230
ILQSystem, Communication, Powered202
IQASystem, Environmental Control, Powered202
PHLPowered Exoskeleton220
SGTElectromagnetic Stimulator For Healthy Muscle Stimulation220
IKTElectrode, Needle, Diagnostic Electromyograph210
IMJDiathermy, Shortwave, For Use In Applying Therapeutic Deep Heat210
IRTPad, Heating, Powered201
OSDMassager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature210
PFWStationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat210

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