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Well-Life Probe Electrode for Stimulation/EMG Probe Model SA

FDA 510(k)

Class II (US FDA 510(k))

510(k) K222528

by Well-Life Healthcare Limited

Identifiers

510(k) Number
K222528 FDA 510(k)
FDA Product Code
KPI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.5320 FDA 510(k)
Regulation Number
876.5320 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Well-Life Probe Electrode is a non-implantable electrical stimulator designed for use in incontinence applications. It functions as an electrode probe for stimulation and electromyography (EMG) procedures.

This device is regulated under FDA 510(k) clearance as a class 2 medical device. It is identified by model number SA and is categorized under regulation number 876.5320.

Frequently asked questions

What is the primary function of the Well-Life Probe Electrode?

The Well-Life Probe Electrode is a non-implantable electrical stimulator intended for use in incontinence applications. It is specifically designed to facilitate both stimulation and electromyography (EMG) procedures.

What is the regulatory status of this device?

The Well-Life Probe Electrode is a class 2 medical device that has received FDA 510(k) clearance. It is categorized under regulation number 876.5320 and is identified by the product code KPI.

Which specific model is represented by this device?

This device is identified by model number SA. It is manufactured by Well-Life Healthcare Limited and is designed for use in urological and gastroenterological clinical settings.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: 510(k) Premarket Notification - FDA, Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA ..., HaRi · Well-Life Probe Electrode for Stimulation/EMG Probe (Model ..., Well-Life Healthcare Limited FDA Filings - FDA.report, Medical probe for electro-stimulation and training of pelvic floor ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Well-Life Healthcare Limited

Sources (1)

  • FDA 510(k) K222528 24 fields · synced Oct 6, 2026