Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device stimulator, peripheral nerve, non-implanted, for urinary incontinence
Regulation Description Nonimplanted, peripheral electrical continence device.
Product CodeNAM
Regulation Number 876.5310
Device Class 2


Premarket Reviews
ManufacturerDecision
AVATION MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
EXODUS INNOVATIONS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 2 2
2021 2 2
2023 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2 2
Migration or Expulsion of Device 1 1
Output Problem 1 1
Patient-Device Incompatibility 1 1
Therapeutic or Diagnostic Output Failure 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Loss of Power 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Cyanosis 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Urinary Incontinence 1 1
Malaise 1 1
Swelling 1 1
Urinary Retention 1 1
Insufficient Information 1 1
Dehydration 1 1
Pain 1 1
Undesired Nerve Stimulation 1 1
Therapeutic Response, Decreased 1 1
Convulsion/Seizure 1 1
Loss of consciousness 1 1

-
-