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510(k) K232152

NerivioInfinity by Theranica Bioelectronics , Ltd. — Product Code QGT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 2023
Date Received
July 19, 2023
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 Bioelectronics , Ltd.

  • K223169 — Nerivio (February 6, 2023)
  • K203181 — Nerivio, FGD000075-4.7 (January 22, 2021)
  • DEN180059 — Nerivio Migra (May 20, 2019)

Other clearances for product code QGT

  • K250405 — Nerivio; Nerivio Infinity (May 14, 2025)
  • K241756 — Nerivio; NerivioInfinity (October 8, 2024)
  • K223169 — Nerivio (February 6, 2023)
  • K203181 — Nerivio, FGD000075-4.7 (January 22, 2021)
  • K201824 — Nerivio (October 23, 2020)
  • DEN180059 — Nerivio Migra (May 20, 2019)