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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; FM 10/C (CRANIAL ELECTRICAL NERVE STIMULATOR); Icalm; iCALM2; iNishcalm; mindGear; My-O-Calme; Nishcalm; NuCalm; Stim Tens
Classification Name: STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF
Product Code: GZJ
Device Class: 2
Regulation Number: 882.5890
Medical Specialty: Neurology
Registered Establishment Name: Syrma Johari MedTech Limited
Registered Establishment Number: 8040537
Premarket Submission Number: K090052
Owner/Operator: Syrma JoharI MedTech Limited
Owner/Operator Number: 10023876
Establishment Operations: Manufacturer
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