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510(k) Data Aggregation
K Number
K232749Device Name
DOOPANG
Manufacturer
Ybrain, Inc.
Date Cleared
2024-06-11
(277 days)
Product Code
PCC
Regulation Number
882.5891Why did this record match?
Applicant Name (Manufacturer) :
Ybrain, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DOOPANG(YPS-301BD) is indicated for:
- The acute treatment of migraine with or without aura in patients 18 years of age or older.
- The prophylactic treatment of episodic migraine in patients 18 years of age or older.
Device Description
This product is a small, portable product that uses the principle of transcutaneous nerve stimulation. By attaching an electrode to the forehead, it transmits electrical stimulation to the upper branch of the trigeminal nerve transdermally. The electrode surface transmits electric current to the skin to generate action potentials on the nerves and adjusts the output mode (Program 1 and Program 2) to preventative treatment of episodic migraine(60Hz) and acute treatment of migraine(100Hz). Specially designed electrode of this product allows contact with the trigeminal nerve endings associated with migraine headaches. The electrodes give nerve stimulation to the orbital upper branch (V1) inside the forehead skin and transmit it to the trigeminal nervous system. This electrical stimulation is transmitted percutaneously through a bipolar adhesive electrode located on the forehead to preventative treatment of episodic migraine(60Hz) or acute treatment of migraine(100Hz).
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