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510(k) Data Aggregation
K Number
K220161Device Name
Biofeedback Nerve and Muscle Stimulator
Manufacturer
Date Cleared
2022-07-20
(181 days)
Regulation Number
876.5320Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Konmed Technology Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The device is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women and to maintain urinary continence in women.
Device Description
The Biofeedback Nerve and Muscle Stimulator (Model: KM530B, KM531B, KM537) is a type of biofeedback and neuromuscular electrical stimulation therapy device for patients with pelvic floor muscle dysfunction. Through the evaluation of myoelectric signal acquisition, multimedia biofeedback training, electromyography triggered electrical stimulation, passive electrical stimulation training and treatment it helps to strengthen weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women.
The device is battery-powered with a touch screen Liquid Crystal Display (LCD) and offers the user a choice of electromyography (EMG) triggered stimulation (ETS) mode (The device provides a passive pulse stimulation when the level of active contraction of the pelvic floor muscles reaches a threshold by means of electrical feedback from the pelvic floor muscles. 17 (KM536, KM537) or 22 (KM530B, KM531B) pre-set sow-frequency pulses stimulate pelvic floor muscles Electrical Stimulation (STIM) programs with 6 pre-set biofeedback response-based EMG games and the EMG therapy are available for the users. The differences between the model KM536 are only the model's name and the number of STIM Programs. The differences between the model KM531B and KM537 are also only the model's name and the number of STIM Programs.
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