510(k) K203181
- Device
- Nerivio, FGD000075-4.7
- Applicant
- Theranica Bioelectronics Ltd
- 510(k) number
- K203181
- Product code
- QGT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-01-22
- Date received
- 2020-10-26
- Regulation
- 882.5899
- Classification name
- Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Alon Ironi
- Address
- 4 Ha-Omanut St. Poleg Industrial Park Netanya IL 4250574 4250574
FDA Registration Numbers#
- 3015379717
- 3035454575
- 3015549449
Source Documents#
Legacy Summary#
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FDA Review#
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