Intellihab System

Stimulator, Muscle, Powered

CyMedica Orthopedics, Inc.

The following data is part of a premarket notification filed by Cymedica Orthopedics, Inc. with the FDA for Intellihab System.

Pre-market Notification Details

Device IDK210604
510k NumberK210604
Device Name:Intellihab System
ClassificationStimulator, Muscle, Powered
Applicant CyMedica Orthopedics, Inc. 19120 N. Pima Rd. Scottsdale,  AZ  85331
ContactKereshmeh Shahriari
CorrespondentKereshmeh Shahriari
CyMedica Orthopedics, Inc. 19120 N. Pima Rd. Scottsdale,  AZ  85331
Product CodeIPF  
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-01
Decision Date2021-06-03

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