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510(k) Data Aggregation
K Number
K210441Device Name
Incontinence Probe
Manufacturer
Date Cleared
2021-09-17
(217 days)
Regulation Number
876.5320Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Med-link Electronics Tech Co, Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Incontinence Probes are intended to provide electromyographic 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
The Incontinence Probe models PE0001, PE0002, PE0004, PE0005, PE0006, PE0007 , PE0008, PE0009, and PE0010 are stand-alone probes/electrodes, which can be placed inside the adult rectum or female vagina to transmit electrical stimulation signals or pelvic floor EMG signals when connected to pelvic electrical stimulators or EMG biofeedback devices during the treatment of urinary incontinence . All the models are reusable for a single patient except PE0003, which is a disposable vaginal probe. The probes are not packaged with specific floor muscle stimulators and EMG/biofeedback equipment but are compatible with low-frequency (less than 1000Hz working frequency) stimulators or EMG/biofeedback devices that meet the standards of IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-10 and use 2.0 DIN connection. The probes are made of S304 stainless steel and Acrylonitrile-Butadiene-Styrene (ABS). The probes are designed for use in home or clinic by a single user. The probes do not require sterilization but need cleaning for reuse according to the cleaning instructions provided in the instructions for use manual.
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K Number
K181154Device Name
Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure Monitor
Manufacturer
Date Cleared
2019-08-02
(458 days)
Product Code
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Med-link Electronics Tech Co, Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Med-link Wrist Digital Blood Pressure Monitor is non-invasive blood measurement of arterial blood pressure values in adults. It is intended to measure the diastolic, systolic blood presures and pulse rate through an inflatable cuff wrapped around the wrist. It can be used by medical professionals or at home. The cuff circumference is limited to 13.5-19.5 cm.
Med-link Upper Arm Digital Blood Pressure Monitor is non-invasive measurement of arterial blood pressure values in adults. It is intended to measure the diastolic, systolic blood presures and pulse rate through an inflatable cuff wrapped around the upper arm. It can be used by medical professionals or at home. The cuff circumference is limited to 22-32cm.
Device Description
The proposed devices are battery driven automatic non-invasive blood pressure Monitor. It is used for automatically conduct the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult at wrist or upper arm within its claimed range and accuracy by oscillometry technique. Devices are consisted of three main parts: external hardwares (such as cuff), analog circuit, and MCU. The devices have the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time.
The proposed devices are intended to be used in medical facilities or at home and provided non-sterile. The proposed devices have 2 models:
Med-link Wrist Digital Blood Pressure Monitor Model:ESM101
Med-link Upper Arm Digital Blood Pressure Monitor Model:ESM201
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