Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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 a medical device manufactured by Well-Life Healthcare Limited. It received FDA 510(k) clearance on 2022-12-29 under approval 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. It is manufactured by Well-Life Healthcare Limited. The 510(k) number is K222528.

When was Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe Electrode approved by the FDA?

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 approval number K222528.

What company makes 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 manufactured by Well-Life Healthcare Limited.

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

NCT03053791 Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait RECRUITING NCT07604415 Active Versus Passive Anal Sphincter Training in Patients With Fecal Incontinence RECRUITING NCT07534696 Evaluation of Non-Invasive Pelvic Floor Neuromuscular Stimulation for Urinary Incontinence After Prostatectomy ENROLLING_BY_INVITATION NCT07187388 Investigating the Impact of Electrical Stimulation on Facial Pain, Jaw Movement and Oral Health in People With Motor Neuron Disease. RECRUITING NCT06492252 Speech Motor Learning and Retention (Aim 3) RECRUITING NCT02911103 Deep Brain Stimulation Surgery for Focal Hand Dystonia ACTIVE_NOT_RECRUITING

Other Devices by Well-Life Healthcare Limited

K161453WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605A K172809OTC Combo TENS/EMS System K162663WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A K200942Well-Life Garment Electrodes (GM Series) K220524Well-Life Mini TENS Stimulator(WL-23XXC/WL-23XXE Series) K213091Well-Life TENS/EMS/Heating Stimulator

View all 8 devices →

Related Devices (Code: KPI)

K162010HPM-6000UBTL Industries, Inc. K161055Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji – 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15Fuji Dynamics , Ltd. K160773Yarlap IIInternational Trade Group, Inc. K161349Everyway Incontinence Stimulation SystemEveryway Medical Instrument Co., Ltd. K181497HPM-6000UFBTL Industries, Inc. K171430Incontinence Treatment Device, Model LT2061Shenzhen Dongdixin Technology Co., 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.

↑