Proprietary Name: |
FM 10/C; 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: |
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
|