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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Intelect Transport 2 Combo (Neurostimulator and Ultrasound); Intelect Transport 2 Ultrasound
Classification Name: STIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT
Product Code: IMG
Device Class: 2
Regulation Number: 890.5860
Medical Specialty: Physical Medicine
Registered Establishment Name: DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.
Registered Establishment Number: 9616086
Premarket Submission Number: K040285
Owner/Operator: DJO, LLC
Owner/Operator Number: 9015378
Establishment Operations: Manufacturer
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