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510(k) Data Aggregation
K Number
K233576Device Name
Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013; Rectal Probe: KM-502, KM-5018)
Manufacturer
Shenzhen Konmed Technology Co., Ltd.
Date Cleared
2024-02-23
(108 days)
Product Code
KPI, HIR
Regulation Number
876.5320Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Konmed Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Konmed Incontinence Stimulation Electrode include Vaginal Probe KM-504, KM-505, KM-506, KM-507, KM-5013 & Rectal Probe KM-502. KM-5018 are intended to provide electromyographic feedback from pelvic musculature or electrical stimulation to pelvic musculature for the purpose of rehabilitation of weak pelvic floor muscles and restoration of neuromuscular control during the treatment of urinary incontinence.
Device Description
Not Found
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K Number
K202648Device Name
Biofeedback Nerve and Muscle Stimulator
Manufacturer
Shenzhen Konmed Technology Co., Ltd.
Date Cleared
2020-12-08
(88 days)
Product Code
IPF, HCC, KPI
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Konmed Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
As a powered muscle stimulator the Biofeedback Nerve and Muscle Stimulator is indicated for the following conditions:
· Relaxation of muscle spasm
· Prevention or retardation of disuse atrophy
·Increasing local blood circulation
· Muscle re-education
·Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
· Maintaining or increasing range of motion
As a biofeedback device the Biofeedback Nerve and Muscle Stimulator is indicated for the following conditions: · Biofeedback, relaxation and muscle re-education purposes
As a nonimplanted electrical continence device the Biofeedback Nerve and Muscle Stimulator is indicated for the following conditions:
· Acute and ongoing treatment of stress, urge or mixed urinary incontinence and where the following results may improve urinary control: Inhibition of the detruser muscles through reflexive mechanisms and strengthening of pelvic floor muscles.
·Incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles such as the abdominal and the gluteus muscles.
Device Description
This Biofeedback Nerve and Muscle Stimulator is a new type of biofeedback and neuromuscular electrical stimulation therapy device through the evaluation of myoelectric signal acquisition, multimedia biofeedback training, electromyography triggered electrical stimulation, passive electrical stimulation training and treatment.
There are two models of Biofeedback Nerve and Muscle Stimulator which are KM530 and KM531. Their intended use, working principle, product structure and major parameters are all same, apart from the difference of product appearance, and KM531 has several more programs than KM530.
The device is battery-powered with a display screen and offers the user a choice of EMG Test (Only for EMG acquisition, not for electrical stimulation), EMG Game (6 biofeedback responsebased vivid games, active training for the user to contract the muscles of the treatment area, no electrical stimulation is generated), ETS (electromyography triggered stimulation; Only when the EMG value reaches the set threshold, the electrical stimulation is triggered; This module is a combination of active and passive treatment module, which exercise the self-contracting ability of the user), and STIM (Neuromuscular stimulation with fixed programs and customized programs of which parameters can be adjusted under the directions of physicians or professionals).
The device is supplied with vaginally inserted probe used with the device to stimulate the muscle of the pelvic floor (the probe is identical to that used in the model KM518 with 510(k) number K163288). Anal probe is optional, user can choose to purchase qualified probe. The device is supplied with biofeedback reference lead wire with skin electrodes. The device main unit connects directly to the vaginal electrode and reference wire by cable and plug. The device provides independent dual-channel EMG signals acquisition and dual-channel electrical stimulation output which is convenient for the treatment of different sites.
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K Number
K163288Device Name
Pelvifine Pelvic Muscle Trainer
Manufacturer
Shenzhen Konmed Technology Co., Ltd.
Date Cleared
2018-01-18
(422 days)
Product Code
KPI
Regulation Number
876.5320Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Konmed Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pelvifine Pelvic Muscle Trainer (Model: KM518) is a non-implanted muscle stimulator designed to treat stress, urge and/or mixed urinary incontinence in women. It applies stimulation to the pelvic floor muscles and surrounding structures to improve strength and support.
Device Description
The Pelvifine Pelvic Muscle Trainer is a product designed to give women the opportunity to strengthen their pelvic floor muscles. This device is a dual-channel stimulator combining several treatment programs into one unit. Channel B is for the Junior User (who use the device no more than 5 times) and Channel A is for the Senior User (who use the device more than 5 times). It offers full control of Pulse Widths, Rates, Ramp up times, and Work/Rest cycles.
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