FDA 510(k)

Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes

Número K: K231166 · 2024-01-18

Data da decisão2024-01-18

Código do produtoKPI

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Zmi Electronics , Ltd.. It received FDA 510(k) clearance on 2024-01-18 under 510(k) number K231166. The device is classified under product code KPI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes?

Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes is a medical device that received FDA 510(k) clearance on 2024-01-18. The listed applicant is Zmi Electronics , Ltd.. The 510(k) number is K231166.

When did Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes receive FDA 510(k) clearance?

Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes received FDA 510(k) clearance on 2024-01-18, under 510(k) number K231166.

Who is the listed applicant for Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes?

The FDA 510(k) record lists Zmi Electronics , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes?

The FDA product code for Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes is KPI.

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Outros registros que listam Zmi Electronics , Ltd. como candidato(a)

K241862Levina Pelvic Floor Muscle Stimulator (RS-48)K180865ZMI Self-Adhesive Electrodes

Dispositivos Relacionados (Código: KPI)

K262353BTL-299-FBTL Industries, Inc.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)Pontemedag

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