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-번호: K222528 · 2022-12-29

결정일2022-12-29

제품 코드KPI

자문 위원회규제 정책: medical-regulatory-v1 GU

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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.

Well-Life Healthcare Limited를 신청인으로 등재한 기타 기록

K233054Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual Relief Stimulator; Well-Life Pain Relief Stimulator; Menstrual Plus Stimulator K220524Well-Life Mini TENS Stimulator(WL-23XXC/WL-23XXE Series)K213091Well-Life TENS/EMS/Heating Stimulator K200942Well-Life Garment Electrodes (GM Series)K172809OTC Combo TENS/EMS System K162663WELL LIFE Rx Wireless TENS/EMS Stimulator, model WR-2603/2603A, WR-2604/2604A and WR-2605/2605A

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