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510(k) DEN180059

Nerivio Migra by Theranica Bioelectronics , Ltd. — Product Code QGT

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
May 20, 2019
Date Received
November 6, 2018
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine
Device Class
Class II
Regulation Number
882.5899
Review Panel
NE
Submission Type

A trunk and limb electrical stimulator to treat headache is a device intended to treat headache through the application of electrical stimulation anywhere on the body of the patient apart from the patient's head or neck through electrodes placed on the skin. The stimulation may be provided transcutaneously or percutaneously.

Other clearances by Theranica Bioelectronics , Ltd.

  • K232152 — NerivioInfinity (November 8, 2023)
  • K223169 — Nerivio (February 6, 2023)
  • K203181 — Nerivio, FGD000075-4.7 (January 22, 2021)

Other clearances for product code QGT

  • K250405 — Nerivio; Nerivio Infinity (May 14, 2025)
  • K241756 — Nerivio; NerivioInfinity (October 8, 2024)
  • K232152 — NerivioInfinity (November 8, 2023)
  • K223169 — Nerivio (February 6, 2023)
  • K203181 — Nerivio, FGD000075-4.7 (January 22, 2021)
  • K201824 — Nerivio (October 23, 2020)