Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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

K-Number: K222528 · 2022-12-29

ApplicantWell-Life Healthcare Limited
Decision Date2022-12-29
Product CodeKPI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT04313192TENS Treatment for BedwettingCOMPLETEDNCT06275282Regenerative Peripheral Nerve Interface for Control of Lower Limb ProsthesesRECRUITINGNCT06285292Prospective and Comparative Evaluation of a Medical Device Composed of a Perineal Probe Connected to a Mobile Application in the Management of Stress Urinary Incontinence.RECRUITING

Other records listing Well-Life Healthcare Limited as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251760Well-Life Incontinence Stimulation System (WL-2405i(P))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 System

View all 9 devices →

Related Devices (Code: KPI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260178Pelvic Muscle Trainer (KM510, KM516B)Shenzhen Konmed Technology Co., Ltd.K252601Pelvic Muscle Trainer (PC22A); Pelvic Muscle Trainer (PC22A-L); Pelvic Muscle Trainer (PC22E); Pelvic Muscle Trainer (PC22E-L)Hunan Accurate Bio-Medical Technology Co., Ltd.K252552Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)Shenzhen Changkun Technology Co., Ltd.K252831Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927)Dolanvy (Suzhou) Medical Technology Co., Ltd.K252334PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)PontemedagK251760Well-Life Incontinence Stimulation System (WL-2405i(P))Well-Life Healthcare , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑