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510(k) K212071

Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx by Cefaly Technology — Product Code PCC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2022
Date Received
July 2, 2021
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

  • K234029 — CEFALY Connected - OTC, CEFALY Connected - Rx (July 18, 2024)
  • 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)
  • K234029 — CEFALY Connected - OTC, CEFALY Connected - Rx (July 18, 2024)
  • K232749 — DOOPANG (June 11, 2024)
  • K233751 — Milieve (YPS-301BD) (June 3, 2024)
  • K230782 — TENS device-HeadaTerm 2 (Model: YF-HT2) (February 26, 2024)
  • 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)