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sTMS Mini

by Eneura, Inc. United States EUDAMED510(k)GUDID

510(k) K161663Ref DWG-0501-UKModel DWG-0500

Product code OKPEMDN V9099

Overview

The sTMS Mini is a Transcranial Magnetic Stimulator designed for the treatment of migraine headache. Classified as a Class II device under FDA regulations, it delivers non-invasive magnetic pulses to the brain to modulate neural activity, targeting acute migraine relief and preventive migraine management.

This portable, single-pulse device is intended for home or clinical use and is supplied sterile for single-patient use. It operates under FDA 510(k) clearance (K161663) and adheres to the Medical Device Directive (MDD). The device is non-reusable, requires no MRI safety considerations, and is stored in its original packaging until use.

Summary written by AI from registry data, 18 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00816140020088 Basic UDI-DIDate6 Nov 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number00816140020088 UDI-DIDate1 Feb 2017ListedStatusIn distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK161663 Date23 Aug 2016ClearedStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring (legacy directive)
  • Not covered
  • European Union CE/MDD Expiring (legacy directive)
  • United States FDA 510(k) Active

Recalls: none on record (FDA, checked 7 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k) · GUDID · synced 7 Oct 2026

Generic Name
Home-use magnetic neural stimulator
Model / Ref / Catalog
DWG-0501-UK, DWG-0500
Primary DI / UDI-DI
00816140020088
Basic UDI-DI
B-00816140020088
510(k) Number
FDA Product Code
OKP
EMDN Code
V9099 Various devices not included in other classes - other
GMDN Term
Home-use magnetic neural stimulator
Device Class
Class IIa EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 882.5808
Market of Registration
Northern Ireland
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent
Commercial Distribution
In Commercial Distribution

Truth per registry

3 sources · 1 field differs

FieldEUDAMED510(k)GUDID
Device ClassEUDAMED
Class IIa
510(k)
Class II
GUDID
Class II

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Questions

  • What is the sTMS mini specifically designed to treat, and how does it work?

    The sTMS mini is designed for the treatment of migraine headaches, both for acute relief and preventive management. It works by delivering non-invasive magnetic pulses to the brain, which modulate neural activity to help alleviate migraine symptoms. This portable device is intended for use in both home and clinical settings.

  • Is the sTMS mini reusable, or is it meant for single-use only?

    The sTMS mini is supplied sterile and intended for single-patient use only, meaning it is non-reusable. This ensures safety and hygiene, as it is designed to be used once and then discarded.

  • How should the sTMS mini be stored before use, and what are the key handling instructions?

    The sTMS mini must be stored in its original packaging until ready for use. This packaging maintains sterility and ensures the device remains uncontaminated. Once opened, it should be used immediately and not reused.

  • Can the sTMS mini be used in an MRI environment, or are there any special safety considerations?

    The sTMS mini does not require any MRI safety considerations, meaning it can be safely used in environments where MRI scans are performed without interference or risk.

  • What regulatory pathways does the sTMS mini follow, and which advisory committee was involved in its review?

    The sTMS mini follows the FDA 510(k) clearance pathway (K161663) and adheres to the Medical Device Directive (MDD). Its review was conducted under the Neurology Advisory Committee (NE) in the FDA’s Special 510(k) process, as indicated by the classification as a Class II device.

Properties & raw data

Show properties, registry sources and raw records
  • Prescription Use
  • Serial Number
  • Manufacturing Date
Other properties (19)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No

Sources (3)

  • FDA 510(k) K161663 24 fields · synced 7 Oct 2026
  • FDA UDI 9beb3489-8d1c-4a5d-9dca-c1d3b66230ac 37 fields · synced 30 May 2026
  • EUDAMED 00816140020088|B-00816140020088 61 fields · synced 8 Jul 2026