Cutaneous Electrode Stimulator For Urinary Incontinence

QAJ · Class II — Moderate Risk (510(k) clearance required) · Gastroenterology, Urology · 21 CFR 876.5330

Classification

FDA Product Code: QAJ
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 876.5330
Review panel: GU
Medical specialty: Gastroenterology, Urology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

A transcutaneous electrical continence device consists of cutaneous electrodes that are used to apply external stimulation to reduce urinary incontinence.

Market data

Cleared 510(k) submissions: 5
Registered establishments: 2

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown