Home / 510(k) Clearances / K253285

510(k) K253285

Elitone for Men by Elidah, Inc. — Product Code QAJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 2026
Date Received
September 29, 2025
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.

  • K223884 — ELITONE Urge Urinary Incontinence Device (February 24, 2023)
  • K183585 — Elitone Device (February 11, 2019)

Other clearances for product code QAJ

  • K223884 — ELITONE Urge Urinary Incontinence Device (February 24, 2023)
  • K192357 — INNOVO (January 16, 2020)
  • K183585 — Elitone Device (February 11, 2019)
  • DEN170049 — Innovo (November 6, 2018)