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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: truFlex; truFlex retractable electrode assembly; truSculpt flex
Classification Name: STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING
Product Code: NGX
Device Class: 2
Regulation Number: 890.5850
Medical Specialty: Physical Medicine
Registered Establishment Name: Johari Digital Healthcare Ltd.
Registered Establishment Number: 8040537
Premarket Submission Number: K212866
Owner/Operator: Johari Digital Healthcare Ltd.
Owner/Operator Number: 10023876
Establishment Operations: Manufacturer
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