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FDA 510(k)

Levina Pelvic Floor Muscle Stimulator (RS-48)

K-Number: K241862 · 2025-03-27

ApplicantZmi Electronics , Ltd.
Decision Date2025-03-27
Product CodeKPI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Levina Pelvic Floor Muscle Stimulator (RS-48) 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 2025-03-27 under 510(k) number K241862. 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 Levina Pelvic Floor Muscle Stimulator (RS-48)?

Levina Pelvic Floor Muscle Stimulator (RS-48) is a medical device that received FDA 510(k) clearance on 2025-03-27. The listed applicant is Zmi Electronics , Ltd.. The 510(k) number is K241862.

When did Levina Pelvic Floor Muscle Stimulator (RS-48) receive FDA 510(k) clearance?

Levina Pelvic Floor Muscle Stimulator (RS-48) received FDA 510(k) clearance on 2025-03-27, under 510(k) number K241862.

Who is the listed applicant for Levina Pelvic Floor Muscle Stimulator (RS-48)?

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 Pelvic Floor Muscle Stimulator (RS-48)?

The FDA product code for Levina Pelvic Floor Muscle Stimulator (RS-48) 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.

NCT07574268Efficacy of Transcutaneous Electrical Neural Stimulation and Tadalafil in Men With Erectile Dysfunction: A Randomized, Double-Blind, Bi-centric, Placebo- and Sham-Controlled TrialCOMPLETEDNCT04734847Motor Cortical Neuromodulation in Women With Interstitial Cystitis/Bladder Pain SyndromeACTIVE_NOT_RECRUITINGNCT05354869Transvaginal Electrical Stimulation for Myofascial Pelvic PainRECRUITINGNCT06517654Comparison of the Effectiveness of EMG-Biofeedback and Rebound Therapy in Patients With EndometriosisCOMPLETEDNCT06532292Physical Therapy Intervention for Pelvic Organ ProlapsesCOMPLETEDNCT07070063Virtual Reality for Urinary Incontinence in WomenCOMPLETED

Other records listing Zmi Electronics , Ltd. 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.

K231166Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe ElectrodesK180865ZMI Self-Adhesive Electrodes

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

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

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