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Incontinence / Obstetrics / Perineometer / Biofeedback / Kegel exercise / Urge incontinence / Pelvic floor / Validation / Urinary incontinence / Medicine / Health / Medical equipment


DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration[removed]New Hampshire Avenue
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Document Date: 2014-11-12 09:21:40

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File Size: 1,66 MB

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City

Rouge / /

Company

Chief Operating Officer Remendium Labs LLC / InCare Pressure Biofeedback Vaginal Probe Manufacturer Remendium Labs LLC / K133990 Trade / Remendium Labs LLC / Hollister Incorporated K / /

Country

United States / /

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Event

FDA Phase / /

Facility

New Hampshire Avenue Document Control Center / /

IndustryTerm

announcements concerning your device / smart phone technology / predicate devices / intracutaneous reactivity protocols / predicate device / insurance / motion electronics / Software validation / medical electrical equipment / home healthcare environment / manufacturing practice requirements / pressure device / marketed predicate devices / sensor systems / manufacturing practice / electrical equipment / software validation testing / Internet address http /

MedicalCondition

urinary incontinence / contraction / mildmoderate urge incontinence / muscle contraction / irritation / mixed urinary incontinence / /

MedicalTreatment

biofeedback / /

Organization

Division of Postmarket Surveillance / Division of Industry and Consumer Education / Food and Drug Administration / Center for Devices and Radiological Health / Division of Reproductive / DEPARTMENT OF HEALTH / New Hampshire Avenue Document Control Center / Device Evaluation Center for Devices and Radiological Health Enclosure / CDRH's office of Surveillance / Reproductive / Gastro-Renal / and Urological Devices Office / /

Person

Silver Spring / Benjamin R. Fisher / Herbert P. Lerner / Yolanda Lorie / /

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Position

Director / physician / General / Officer / /

Product

RPD / Federal Food / /

ProvinceOrState

Maryland / Louisiana / /

Technology

Biofeedback / radiation / smart phone technology / smartphone / Simulation / intracutaneous reactivity protocols / /

URL

http /

SocialTag