CyMedica E-vive™ System; CY-1000

Stimulator, Muscle, Powered

CyMedica Orthopedics, Inc.

The following data is part of a premarket notification filed by Cymedica Orthopedics, Inc. with the FDA for Cymedica E-vive™ System; Cy-1000.

Pre-market Notification Details

Device IDK163067
510k NumberK163067
Device Name:CyMedica E-vive™ System; CY-1000
ClassificationStimulator, Muscle, Powered
Applicant CyMedica Orthopedics, Inc. 19120 N. Pima Rd. Suite 135 Scottsdale,  AZ  85255
ContactKereshmeh Shahriari
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeIPF  
Subsequent Product CodeGZJ
Subsequent Product CodeKQX
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2016-11-02
Decision Date2016-12-01
Summary:summary

NIH GUDID Devices

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