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510(k) K223884

ELITONE Urge Urinary Incontinence Device by Elidah, Inc. — Product Code QAJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 2023
Date Received
December 27, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cutaneous Electrode Stimulator For Urinary Incontinence
Device Class
Class II
Regulation Number
876.5330
Review Panel
GU
Submission Type

A transcutaneous electrical continence device consists of cutaneous electrodes that are used to apply external stimulation to reduce urinary incontinence.

Other clearances by Elidah, Inc.

  • K253285 — Elitone for Men (January 23, 2026)
  • K183585 — Elitone Device (February 11, 2019)

Other clearances for product code QAJ

  • K253285 — Elitone for Men (January 23, 2026)
  • K192357 — INNOVO (January 16, 2020)
  • K183585 — Elitone Device (February 11, 2019)
  • DEN170049 — Innovo (November 6, 2018)