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510(k) Data Aggregation
K Number
K130951Device Name
SIM
Manufacturer
SIMAVITA PTY LIMITED
Date Cleared
2013-08-22
(139 days)
Product Code
KPN
Regulation Number
876.2040Why did this record match?
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Matched: '876.2040'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SIM™ (Smart Incontinence Management) is indicated for use by healthcare professionals to remotely monitor wetness events, and collect, transmit and report wetness events and other medical information from multiple patients within a clinical setting (e.g., hospitals, skilled nursing facilities, residential care facilities), to establish effective management care plans for continence events.
Device Description
SIM™ consists of disposable incontinence pads with embedded sensors, a wireless transceiver, hardware, and software.
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K Number
K971442Device Name
HUGHES BLADDER AND BOWEL TRAINING SYSTEM(AD-T-18, MED-18,MED-1,MED-T-1,MEDD-18,MED-38,MED-T-10,MED-T-25,MED-T-5
Manufacturer
HUMED, INC.
Date Cleared
1998-01-08
(262 days)
Product Code
KPN
Regulation Number
876.2040Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The proposed product, Hughes Bowel and Bladder System Model MeD-18, is an enuresis alarm, a device to detect urine and/or feces and to set off a vibratory alarm when detected, that may be used by an ambulatory adult to assist in the control of incontinence.
Hughes Bowel and Madder System model MeD-18 helps persons with incontinence manage of overcome bladder control problems by providing them with a private alarm system to detect when uncontrolled urination or excretion begins.
Hughes Bowel and Bladder System, model MeD-18, assists in controlling incontinence so that the wearer can manage their comditon promptly and with complete discretion at the first sign of bladder or bowel release day or night.
Device Description
The proposed product, Hughes Bowel and Bladder System Model MeD-18, is an enuresis alarm, a device to detect urine and/or feces and to set off a vibratory alarm when detected, that may be used by an ambulatory adult to assist in the control of incontinence.
The device functions with a pager-like motor that vibrates to inform the wearer of urine / feces spillage.
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K Number
K971855Device Name
POTTY PAL AND FOREVER-DRY
Manufacturer
DIGITAL APPLICATIONS, INC.
Date Cleared
1997-08-18
(90 days)
Product Code
KPN
Regulation Number
876.2040Why did this record match?
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Matched: '876.2040'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Potty Pal: This device is indicated as a daytime enuresis alarm that may be used by a parent or caregiver to assist toddlers in toilet training.
Forevery Dry: This device is indicated as nighttime enuresis alarm to aid in solving a child's nighttime bedwetting problem.
Device Description
The Forever Dry and Potty Pal consist of: Training parts, which has sewn in mylas conductive strips. The strips are connected to an audible alarm. Powered by a 9V battery
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