Incontrol Medical Fda

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510(k) Premarket Notification - Food and Drug …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=k110179

INCONTROL MEDICAL, LLC: 12715 FALCON DRIVE: BROOKFIELD, WI 53005 Applicant Contact: MICHAEL LEIGH: Correspondent: INCONTROL MEDICAL, LLC: 12715 FALCON DRIVE ... MD 20993 Ph. 1-888-INFO-FDA (1-888-463-6332) Contact FDA. For …

March 15, 2019 InControl Medical, LLC Jennifer …

https://www.accessdata.fda.gov/cdrh_docs/pdf18/K182022.pdf

**The InControl Medical Electrode Gel is privately labeled for InControl Medical. It is a Pre‐ Amendment Class II Medical Device under D039725. The kit contents are …

The Cure For Incontinence | InControl Medical

https://www.incontrolmedical.com/

The Cure For Incontinence | InControl Medical. InControl Medical is the world’s leading provider of home pelvic therapy and kegel excerciser devices for the use of curing bladder leakage and incontinence. …

InControl Medical Wins FDA Clearance for Attain: The First Over …

https://simonfoundation.org/incontrol-fda-clearance-attain/

InControl Medical wins FDA clearance for new Attain, the first over-the-counter (OTC) non-implantable muscle stimulator designed for at-home use to help treat the …

Frequently Asked Questions (FAQs) About InControl …

https://www.incontrolmedical.com/faq/

InControl Medical Gel is a conductive gel that enhances the delivery of stimulation and the effectiveness of our devices, and also functions as a lubricant. The gel has been …

Submitter: InControl Medical, F 2 2 2012 - Food and …

https://www.accessdata.fda.gov/cdrh_docs/pdf11/K110179.pdf

The InControl InTone device is a non-implanted electrical stimulator indicated for use in the treatment of female urinary incontinence. It applies electrical stimulation to the …

Brookfield InControl Medical sparks customer complaints

https://www.jsonline.com/story/news/investigations/public-investigator/2022/11/22/brookfield-incontrol-medical-sparks-customer-complaints/7865382001/

InControl Medical, founded in 2010, designs and manufactures products that aid with bladder leakage and incontinence. Earlier this year, customers began reporting that items they had …

MAUDE Adverse Event Report: INCONTROL MEDICAL, …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=10836622&pc=KPI

INCONTROL MEDICAL, LLC ATTAIN, APEX STIMULATOR, ELECTRICAL, NON-IMPLANTABLE, FOR INCONTINENCE. Back to Search Results. Device …

Intensity - Kegel Exerciser with a kick - InControl Medical

https://www.incontrolmedical.com/about-intensity/

Intensity was born from a medical device, and is the only intimate health product available that combines pleasure with pelvic floor toning, giving you a workout you’ll look forward to. The pelvic floor is a group of …

Class 2 Device Recall HEB InControl Insulin Syringe

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=196691

Class 2 Device Recall HEB InControl Insulin Syringe Class 2 Device Recall HEB InControl Insulin Syringe FDA Home Medical Devices Databases 510 (k) | DeNovo …

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