KONMED /Pelvifine
Shenzhen Konmed Technology Co., Ltd. · Model KM531B · UDI-DI 06970935830574
Description
This Biofeedback device 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.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.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-12-11 | RONAN MEDICAL LLC | Neurofeedback systems removed due to missing design and development documentation and devices may not perform as intended. |
| 2017-07-07 | Ondamed Inc | The firm was marketing the Ondamed System in the US without marketing clearance. As a corrective action, the firm revised its device design to comply with regulations. The firm has |
| 2015-10-01 | Powers Medical Devices, LLC | PAL unit has undergone significant technological changes since the previous 510(k) and labeling is not consistent with the cleared indications of the 510(k). |
| 2012-11-15 | EEG Info | EEG Info, Inc. is recalling the EEG Neuroamp device because they have identified a potential risk associated with the mislabeling of certain devices. |
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