QAJClass II
Cutaneous Electrode Stimulator For Urinary Incontinence
Gastroenterology, Urology · 21 CFR 876.5330
A transcutaneous electrical continence device consists of cutaneous electrodes that are used to apply external stimulation to reduce urinary incontinence.
MDR events12All time
Recalls0All time
Registered firms4Currently listed
510(k) clearances5All time
Recent MDR events
12 adverse event reports on file
- INNOVO, TYPE NUMBER 208Mar 14, 2024InjuryAtlantic Therapetucis3015223097-2024-00001
- INNOVO, TYPE NUMBER 207Aug 3, 2023MalfunctionAtlantic Therapeutics3015223097-2023-00010
- INNOVO, TYPE NUMBER 208Aug 3, 2023MalfunctionAtlantic Therapeutics Ltd3015223097-2023-00011
- INNOVO, TYPE NUMBER 208Aug 3, 2023MalfunctionAtlantic Therapeutics Ltd3015223097-2023-00012
- INNOVO, TYPE NUMBER 207Jul 14, 2023InjuryAtlantic Therapeutics Ltd3015223097-2023-00009
- INNOVO, TYPE NUMBER 207May 24, 2023InjuryAtlantic Therapeutics Ltd3015223097-2023-00077
- INNOVONov 7, 2022InjuryAtlantic Therapeutics LimitedMW5113105
- INNOVO®, TYPE NUMBER 208Oct 17, 2022InjuryAtlantic Therapeutics Ltd3015223097-0722-00077
- INNOVO®, TYPE NUMBER 208Oct 14, 2022InjuryAtlantic Therapeutics Ltd3015223097-0722-00065
- INNOVO®, TYPE NUMBER 207Oct 14, 2022InjuryAtlantic Therapeutics Ltd,3015223097-0922-00064
Event type breakdown
Injury9
Malfunction3
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
4 firms currently registered for this product code
510(k) clearances
5 clearances for this product code