ClearanceBrief
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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 I

CodeDeviceClass510(k)s, 12 moRecalls, 12 mo
IORWheelchair, Mechanical1200
ISAMassager, Therapeutic, Electric103
ITJWalker, Mechanical102
IMEPack, Hot Or Cold, Reusable101
INNChair, Adjustable, Mechanical101
ITGBandage, Cast101
KNNComponents, Wheelchair101
QYNPrescription Audiovisual Stimulator (Avs) For Temporary Pain Relief (Adjunctive Use)110

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