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510(k) K250405

Nerivio; Nerivio Infinity by Theranica Bio-Electronics, Ltd. — Product Code QGT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 2025
Date Received
February 13, 2025
Clearance Type
Traditional
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 Bio-Electronics, Ltd.

  • K241756 — Nerivio; NerivioInfinity (October 8, 2024)
  • K201824 — Nerivio (October 23, 2020)

Other clearances for product code QGT

  • 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)
  • DEN180059 — Nerivio Migra (May 20, 2019)