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510(k) K192357

INNOVO by Atlantic Therapeutics, Ltd. — Product Code QAJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 2020
Date Received
August 29, 2019
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 for product code QAJ

  • K253285 — Elitone for Men (January 23, 2026)
  • K223884 — ELITONE Urge Urinary Incontinence Device (February 24, 2023)
  • K183585 — Elitone Device (February 11, 2019)
  • DEN170049 — Innovo (November 6, 2018)