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Device Explorer · FDA GUDID · GMDN 58832

Migraine-therapy peripheral nerve electrical stimulator

A portable electrically-powered device designed to non-invasively stimulate a peripheral nerve(s) [including vagus nerve] in the neck, trunk or extremity to treat or prevent symptoms of migraine/headaches. It typically consists of a unit with operator controls

US‑registered devices95in commercial distribution
Companies4labelers on GUDID
Single‑use2%of device records
Sterile0%labelled sterile
Prescription95%Rx‑only share
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Share of device records

Electrocore, Inc.8691%
Theranica Bio-Electronics Ltd.55%
Wuxi Jiajian Medical Instrument Co.,Ltd.33%
Ybrain Inc.11%

Top labelers

CompanyDevicesShare
Electrocore, Inc.8691%
Theranica Bio-Electronics Ltd.55%
Wuxi Jiajian Medical Instrument Co.,Ltd.33%
Ybrain Inc.11%

Company = labeler of record on GUDID. 4 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Nerivio Infinity RefillNerivio InfinityNeriviogammaCore Refill CardgmmaCore - Refill CardgammaCore EmeraldgammaCore SapphiregammaCore Emerald Replacement Power BlockgammaCore Emerald Replacement USB CablegammaCore Emerald Replacement Charging PadgammaCore Emerald Handset - ReplacementgammaCore 12-Month CardgammaCore 3-Month CardgammaCore 1-Month CardgammaCore Emerald 36-Month Licensed Device KitgammaCore Emerald 12-Month Licensed Device Kit

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
PKRNon-Invasive Vagus Nerve Stimulator - Headache86
QAKNon-Invasive Vagus Nerve Stimulator For Migraine Headache86
QGTDistal Transcutaneous Electrical Stimulator For Treatment Of5
BWKStimulator, Electro-Acupuncture3
PCCStimulator, Nerve, Electrical, Transcutaneous, For Migraine1

GMDN & GCC registration

  • GMDN code 58832 · non‑implantable
  • Single‑use 2% · sterile 0% · Rx‑only 95% · OTC 2%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

Use these as the dimensions to specify in a tender line.

No closely related category with 50+ devices.

How many migraine-therapy peripheral nerve electrical stimulator products are registered in the US?

95 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Migraine-therapy peripheral nerve electrical stimulator", from 4 companies. The largest labeler is Electrocore, Inc. with 91% of records.

Which FDA product codes apply?

PKR (Non-Invasive Vagus Nerve Stimulator - Headache), QAK (Non-Invasive Vagus Nerve Stimulator For Migraine Headache), QGT (Distal Transcutaneous Electrical Stimulator For Treatment Of), BWK (Stimulator, Electro-Acupuncture)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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