510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QAJClass II

Cutaneous Electrode Stimulator For Urinary Incontinence

21 CFR 876.5330 / Gastroenterology, Urology
FDA source (opens on fda.gov)

QAJ is the FDA product code for Cutaneous Electrode Stimulator For Urinary Incontinence, a class II device type, regulated under 21 CFR 876.5330. FDA's definition for this code reads: "A transcutaneous electrical continence device consists of cutaneous electrodes that are used to apply external stimulation to reduce urinary incontinence". As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QAJ
Device name
Cutaneous Electrode Stimulator For Urinary Incontinence
FDA definition
A transcutaneous electrical continence device consists of cutaneous electrodes that are used to apply external stimulation to reduce urinary incontinence.
Regulation
21 CFR 876.5330
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
5
Ingested recalls
0

Clearances, product code QAJ

By decision year
5 clearances under product code QAJ with a decision year between 2018 and 2026, 2018 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QAJ by decision year
YearClearances
20181
20191
20201
20231
20261

Applicants with the most clearances

Product code QAJ
Applicants holding the most 510(k) clearances under product code QAJ
ApplicantClearances
Elidah3
Atlantic Therapeutics, Ltd.1
Bio-Medical Research, Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code