QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve Stimulator

Stimulator, Muscle, Powered

CyMedica Orthopedics, Inc.

The following data is part of a premarket notification filed by Cymedica Orthopedics, Inc. with the FDA for Qb1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve Stimulator.

Pre-market Notification Details

Device IDK150413
510k NumberK150413
Device Name:QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve Stimulator
ClassificationStimulator, Muscle, Powered
Applicant CyMedica Orthopedics, Inc. 19120 N. Pima Rd. Suite 135 Scottsdale,  AZ  85255
ContactKereshmeh Shahriari
CorrespondentDave Yungvirt
THIRD PARTY REVIEW GROUP, LLC 45 ROCKEFELLER PLAZA SUITE 2000 New York,  NY  10111
Product CodeIPF  
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2015-02-18
Decision Date2015-04-02
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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