Doopang Transcutaneous Electrical Nerve Stimulator
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Ybrain, Inc.
Identifiers
- 510(k) Number
- K232749 FDA 510(k)
- FDA Product Code
- PCC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5891 FDA 510(k)
- Regulation Number
- 882.5891 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Doopang is a transcutaneous electrical nerve stimulator classified as a nerve stimulator for migraine relief. It employs TENS technology to deliver controlled electrical impulses to the trigeminal nerve, targeting pain signal transmission associated with migraine episodes. This device is designed to provide non-invasive, medication-free migraine management by modulating nerve activity.
The Doopang is supplied as a portable, single-use or reusable device (as per regulatory context) and is intended for home or clinical use. It operates under FDA 510(k) clearance (K232749) and MDD authorization, adhering to Class II medical device standards. The device requires no special storage conditions and is intended for adult migraine sufferers seeking alternative pain relief methods. No MRI safety data is specified.
Frequently asked questions
What is the primary purpose of the Doopang device, and how does it work to help migraine sufferers?
The Doopang is a transcutaneous electrical nerve stimulator (TENS) designed specifically for migraine relief. It uses TENS technology to deliver controlled electrical impulses to the trigeminal nerve, which helps modulate pain signals associated with migraine episodes. By targeting nerve activity non-invasively, it provides a medication-free approach to managing migraine pain at home or in clinical settings.
Is the Doopang device reusable, or is it intended for single-use only?
The Doopang is supplied as a portable device that can be either single-use or reusable, depending on the regulatory context in which it is used. This flexibility allows for adaptability in both home and clinical environments, though the specific reuse guidelines should be followed as per local regulatory requirements.
Are there any special storage requirements for the Doopang device?
No, the Doopang does not require any special storage conditions. It can be stored under standard environmental conditions, making it convenient for both home and clinical use without additional handling precautions.
What regulatory pathways has the Doopang device followed, and which medical specialty does it fall under?
The Doopang has received FDA 510(k) clearance (K232749) under the Traditional pathway, with a decision described as Substantially Equivalent. It is also authorized under the Medical Devices Directive (MDD) and is classified as a Class II medical device. The device falls under the Neurology medical specialty, as indicated by its advisory committee designation and OpenFDA categorization.
Can the Doopang device be used safely in environments where MRI scans are performed?
The Doopang device does not specify MRI safety data, meaning its compatibility with MRI environments (such as whether it can be safely used near MRI machines or if it contains metallic components) is not confirmed. Clinicians should exercise caution and consult manufacturer guidelines before using it in or near MRI facilities.
This description and any FAQs above were generated automatically from registry data 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. Sources consulted: Product - YBRAIN, Doopang - Halomedicals Systems - USA, K232749 FDA 510 (k) - DOOPANG | Ybrain, Inc.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K232749 | Class II | Active |
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Manufacturer
- Manufacturer
- Ybrain, Inc.
Sources (2)
- FDA 510(k) K232749 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026