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FDA 510(k)

Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe Electrode

N.º K: K222528 · 2022-12-29

SolicitanteWell-Life Healthcare Limited
Fecha de decisión2022-12-29
Código de productoKPI
Comité asesorGU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Well-Life Healthcare Limited. It received FDA 510(k) clearance on 2022-12-29 under 510(k) number K222528. The device is classified under product code KPI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe Electrode?

Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe Electrode is a medical device that received FDA 510(k) clearance on 2022-12-29. The listed applicant is Well-Life Healthcare Limited. The 510(k) number is K222528.

When did Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe Electrode receive FDA 510(k) clearance?

Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe Electrode received FDA 510(k) clearance on 2022-12-29, under 510(k) number K222528.

Who is the listed applicant for Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe Electrode?

The FDA 510(k) record lists Well-Life Healthcare Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe Electrode?

The FDA product code for Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe Electrode is KPI.

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Otros registros que enlistan a Well-Life Healthcare Limited como solicitante

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K233054Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual Relief Stimulator; Well-Life Pain Relief Stimulator; Menstrual Plus StimulatorK220524Well-Life Mini TENS Stimulator(WL-23XXC/WL-23XXE Series)K213091Well-Life TENS/EMS/Heating StimulatorK200942Well-Life Garment Electrodes (GM Series)K172809OTC Combo TENS/EMS SystemK162663WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A

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Dispositivos relacionados (Código: KPI)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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