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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: FM 10/C; iCALM; iCALM2; iNishcalm; mindGear; My-O-Calme; Nishcalm; NuCalm; Stim Tens
Classification Name: CRANIAL ELECTROTHERAPY STIMULATOR TO TREAT INSOMNIA AND/OR ANXIETY
Product Code: QJQ
Device Class: 2
Regulation Number: 882.5800
Medical Specialty: Neurology
Registered Establishment Name: Johari Digital Healthcare Ltd.
Registered Establishment Number: 8040537
Premarket Submission Number: K090052
Owner/Operator: Johari Digital Healthcare Ltd.
Owner/Operator Number: 10023876
Establishment Operations: Manufacturer
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