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Health / Electrotherapy / Medical equipment / Neuroprosthetics / Functional electrical stimulation / Neurotechnology / Medical device / Premarket approval / Stationary bicycle / Medicine / Technology / Food and Drug Administration


Document Date: 2011-05-30 00:44:00

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City

Baltimore / /

Company

HUMAN SERVICES Restorative Therapies Inc / Flywheel Wireless / RESTORATIVE THERAPIES INC. / Andrew Barriskill Restorative Therapies Inc / /

Event

FDA Phase / Product Issues / /

IndustryTerm

announcements concerning your device / predicate devices / predicate device / manufacturing practice requirements / wireless battery / marketed predicate devices / manufacturing practice / wireless single channel stimulators / ___________weight Wireless battery / energy / technology comparison / marketed device / Internet address http / /

MedicalCondition

muscle spasms / disuse atrophy / /

MedicalTreatment

Relaxation / /

Organization

Division of Postmarket Surveillance / Division of Ophthalmic / Neurological / and Ear / Food and Drug Administration / CDRH' s office of Surveillance / Center for Devices and Radiological Health / office of Compliance / office of Device Evaluation / Device Evaluation Center for Devices and Radiological Health Enclosure Indications for Use / Division of Small Manufacturers / International and Consumer Assistance / DEPARTMENT OF HEALTH / Division of Ophthalmic / Ear / Nose and Throat Devices Office / /

Person

Barriskill / /

/

Position

FES controller / controller / motor controller and drive assembly / Director / RT5O stimulators __________stimulators Controller / controller / /

Product

Federal Food / lower extremity movement / K090750 / /

ProvinceOrState

Maryland / /

Technology

radiation / http / /

URL

http /

SocialTag