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510(k) K234029

CEFALY Connected - OTC, CEFALY Connected - Rx by Cefaly Technology — Product Code PCC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2024
Date Received
December 20, 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 by Cefaly Technology

  • K212071 — Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefal (December 13, 2022)
  • K201895 — Cefaly Dual (September 29, 2020)
  • K173006 — Cefaly Dual (November 28, 2017)
  • K171446 — Cefaly Acute (September 15, 2017)
  • K160237 — Cefaly (March 4, 2016)

Other clearances for product code PCC

  • K242719 — ELEXIR 2.0 (ALLIVE3) (November 6, 2024)
  • K232749 — DOOPANG (June 11, 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)
  • K201895 — Cefaly Dual (September 29, 2020)