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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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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: Johari Digital Healthcare Ltd.
Registered Establishment Number: 8040537
Premarket Submission Number: K102190
Owner/Operator: Johari Digital Healthcare Ltd.
Owner/Operator Number: 10023876
Establishment Operations: Manufacturer
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