FDA.reportPublic FDA data

Incontinence sensor/alarm

Definition
A electrically-powered electronic device intended to provide an audible, visible and/or tactile signal to alert the patient or a caregiver when a small quantity of urine and/or faeces incontinently released is detected by a sensing mechanism (e.g., a sensor pad or detector). It is typically used in the treatment of nocturnal bedwetting (enuresis) in a child or a person with a disability, and may be used in the home or a healthcare facility.
GUDID devices
141
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00193489036414FITRIGHTMEDLINE INDUSTRIES, INC.MSAPOD12026-03-05
09342124000179SIM pants RegularSIMAVITA (AUST) PTY LTD13032016-06-03
09342124000407SIM pants XLSIMAVITA (AUST) PTY LTD13052016-06-03
09342124000414SIM pants XXLSIMAVITA (AUST) PTY LTD13072016-06-03
10193489082739FITRIGHTMEDLINE INDUSTRIES, INC.MSACHAR012026-03-05
10193489036411FITRIGHTMEDLINE INDUSTRIES, INC.MSAPOD12026-03-05
20193489082736FITRIGHTMEDLINE INDUSTRIES, INC.MSACHAR012026-03-05
00619013000015DRI Sleeper excelANZACARE LIMITEDAZ-0012026-02-16
00619013000039DRI Sleeper eclipseANZACARE LIMITEDAZ-0032026-02-16
00619013000183DRI Sleeper eclipse plusANZACARE LIMITEDAZ-0142026-02-16
00854950002689ChummieTheos Medical Systems, Inc.TCE25B2026-01-01
00854950002696ChummieTheos Medical Systems, Inc.TCE25P2026-01-01
00854950002702ChummieTheos Medical Systems, Inc.TCE25O2026-01-01
00854950002719ChummieTheos Medical Systems, Inc.TCE25G2026-01-01
00856455007428Wicked SmartWicked Sheets, LLCVersion 12025-11-19
00854950002023ChummieTheos Medical Systems, Inc.TC300B2024-01-04
00854950002030ChummieTheos Medical Systems, Inc.TC300P2024-01-04
00854950002047ChummieTheos Medical Systems, Inc.TCI3002024-01-04
00854950002078ChummieTheos Medical Systems, Inc.TC310B2024-01-04
00854950002085ChummieTheos Medical Systems, Inc.TC310P2024-01-04
00854950002153ChummieTheos Medical Systems, Inc.TC300G2024-01-04
00854950002177ChummieTheos Medical Systems, Inc.TCE25B2024-01-04
00854950002184ChummieTheos Medical Systems, Inc.TCE25P2024-01-04
00854950002191ChummieTheos Medical Systems, Inc.TCE25O2024-01-04
00854950002207ChummieTheos Medical Systems, Inc.TCE25G2024-01-04
00854950002269GuardianTheos Medical Systems, Inc.TGV65W2024-01-04
00854950002283ShieldTheos Medical Systems, Inc.TSM45G2024-01-04
00854950002290ShieldTheos Medical Systems, Inc.TSM45S2024-01-04
00854950002320ChummieTheos Medical Systems, Inc.TC310G2024-01-04
00854950002559NewUTheos Medical Systems, Inc.TNU4B2024-01-04
00854950002566SmartTheos Medical Systems, Inc.TSV55W2024-01-04
00854950002573ZestTheos Medical Systems, Inc.TZT4G2024-01-04
00854950002580SmartTheos Medical Systems, Inc.TSV50W2024-01-04
00854950002597ShieldTheos Medical Systems, Inc.TSP40R2024-01-04
00854950002603ShieldTheos Medical Systems, Inc.TSP40B2024-01-04
07350078441001PjamaPjama ABPjama Treatment Pants Grey Age 3-4 - 98/104 2023-11-15
07350078441018PjamaPjama ABPjama Treatment Pants Grey Age 5-6 - 110/1162023-11-15
07350078441025PjamaPjama ABPjama Treatment Pants Grey Age 6-8 - 122/128 2023-11-15
07350078441032PjamaPjama ABPjama Treatment Pants Grey Age 8 - 10 - 134/140 2023-11-15
07350078441049PjamaPjama ABPjama Treatment Pants Grey Age 10-12 - 146/152 2023-11-15
07350078441056PjamaPjama ABPjama Treatment Pants Grey SMALL - 158/1642023-11-15
07350078441155PjamaPjama ABPjama Treatment Shorts Grey Age 3-4 - 98/104 2023-11-15
07350078441162PjamaPjama ABPjama Treatment Shorts Grey Age 5-6 - 110/1162023-11-15
07350078441179PjamaPjama ABPjama Treatment Shorts Grey Age 6-8 - 122/128 2023-11-15
07350078441186PjamaPjama ABPjama Treatment Shorts Grey Age 8 - 10 - 134/140 2023-11-15
07350078441193PjamaPjama ABPjama Treatment Shorts Grey Age 10-12 - 146/152 2023-11-15
07350078441209PjamaPjama ABPjama Treatment Pants Grey SMALL - 158/1642023-11-15
07350078441308PjamaPjama ABPjama Bedwetting Alarm2023-11-15
07350078441315PjamaPjama ABPjama Speaker2023-11-15
07350078441322PjamaPjama ABPjama Sensor2023-11-15
07350078441490PjamaPjama ABPjama Connect Bedwetting Alarm2023-11-15
07350078441537PjamaPjama ABTreatment Boxers Underwear darkblue- Size 199 XXL2023-11-15
07350078441704PjamaPjama ABTreatment Briefs Underwear purple - Size 110/1162023-11-15
07350078441711PjamaPjama ABTreatment Briefs Underwear purple - Size 122/1282023-11-15
07350078441728PjamaPjama ABTreatment Briefs Underwear purple - Size 134/1402023-11-15
07350078441735PjamaPjama ABTreatment Briefs Underwear purple - Size 146/1522023-11-15
07350078441742PjamaPjama ABTreatment Briefs Underwear purple - Size 158/1642023-11-15
07350078441759PjamaPjama ABTreatment Boxers Underwear darkblue- Size 110/1162023-11-15
07350078441766PjamaPjama ABTreatment Boxers Underwear darkblue- Size 122/1282023-11-15
07350078441773PjamaPjama ABTreatment Boxers Underwear darkblue- Size 134/1402023-11-15
07350078441780PjamaPjama ABTreatment Boxers Underwear darkblue- Size 146/1522023-11-15
07350078441797PjamaPjama ABTreatment Boxers Underwear darkblue- Size 158/1642023-11-15
07350078441902PjamaPjama ABTreatment Boxers Underwear darkblue- Size 170/1762023-11-15
07350078441919PjamaPjama ABTreatment Boxers Underwear darkblue- Size 182/1882023-11-15
07350078444354PjamaPjama ABTreatment Briefs Underwear purple - Size 170/176 M2023-11-15
07350078444361PjamaPjama ABTreatment Briefs Underwear purple - Size 182/188 L2023-11-15
07350078445078PjamaPjama ABTreatment Boxers Underwear darkblue- Size 194 XL2023-11-15
07350078445160DryGuardiansPjama ABDryGuardians App2023-11-15
00854636006499Parasol Wireless Patient Fall Prevention SystemParasol Medical, LLCQC-042022-12-07
00854636006529Parasol Patient Fall Prevention SystemParasol Medical, LLCQC-032022-12-07
G137DE3000DryEasyMarvelworks LimitedDE3002022-02-28
G137DE100TS0DryEasyMarvelworks LimitedDE100TS2021-09-06
09342124000162SIM pants RegularSIMAVITA (AUST) PTY LTD13032016-06-03
09342124000285SIM pod kitSIMAVITA (AUST) PTY LTD60102016-07-13
09342124000292SIM pod kitSIMAVITA (AUST) PTY LTD60102016-07-13
09342124000308SIM pod kitSIMAVITA (AUST) PTY LTD60102016-07-13
09342124000315SIM sensor LIGHT kitSIMAVITA (AUST) PTY LTD60152016-07-22
09342124000322SIM sensor MODERATE kitSIMAVITA (AUST) PTY LTD60162016-07-22
09342124000339SIM sensor HEAVY kitSIMAVITA (AUST) PTY LTD60172016-07-22
09342124000346SIM™ podSIMAVITA (AUST) PTY LTD60192016-05-04