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510(k) K232749

DOOPANG by Ybrain, Inc. — Product Code PCC

K232749 is an FDA 510(k) premarket notification submitted by Ybrain, Inc. for the device "DOOPANG". The FDA issued a decision of Substantially Equivalent on June 11, 2024. The device falls under product code PCC (Stimulator, Nerve, Electrical, Transcutaneous, For Migraine), a Class II device regulated under 21 CFR 882.5891.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 2024
Date Received
September 8, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
Device Class
Class II
Regulation Number
882.5891
Review Panel
NE
Submission Type

Used to apply an electrical current to a patient's cranium through electrodes placed on the skin.

Other clearances for product code PCC

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  • K242719 — ELEXIR 2.0 (ALLIVE3) (November 6, 2024)
  • K234029 — CEFALY Connected - OTC, CEFALY Connected - Rx (July 18, 2024)
  • K233751 — Milieve (YPS-301BD) (June 3, 2024)
  • K230782 — TENS device-HeadaTerm 2 (Model: YF-HT2) (February 26, 2024)
  • K212071 — Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefal (December 13, 2022)
  • K212106 — Relivion (August 2, 2021)
  • K211380 — Elexir (July 30, 2021)
  • K210364 — Migraine Tens Digital Pain Reliever (June 17, 2021)
  • K203419 — Relivion (February 16, 2021)

FDA data resources