KneeKG system P-142

GUDID 00627843933236

Emovi Inc

Gait analysis system
Primary Device ID00627843933236
NIH Device Record Key6c0e25be-c6bb-4e18-ab7d-fd1633eb9b6a
Commercial Distribution StatusIn Commercial Distribution
Brand NameKneeKG system
Version Model Number0
Catalog NumberP-142
Company DUNS247640605
Company NameEmovi Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100627843933236 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXJInteractive Rehabilitation Exercise Devices

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-31
Device Publish Date2022-03-23

Devices Manufactured by Emovi Inc

00627843933236 - KneeKG system2022-03-31
00627843933236 - KneeKG system2022-03-31
00627843933243 - KneeKG-Exoskeleton2022-03-28

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