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510(k) DEN170049

Innovo by Bio-Medical Research, Ltd. — Product Code QAJ

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
November 6, 2018
Date Received
September 18, 2017
Clearance Type
Direct
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.

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