myoRESEARCH3 (MR3) 402

GUDID 00816271020711

MR3 - myoMUSCLE

Noraxon U.S.A., Inc.

Biomechanical function analysis/rehabilitation software
Primary Device ID00816271020711
NIH Device Record Keya621295e-d431-4b21-9252-152c34027697
Commercial Distribution StatusIn Commercial Distribution
Brand NamemyoRESEARCH3 (MR3)
Version Model Number402
Catalog Number402
Company DUNS611243809
Company NameNoraxon U.S.A., Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datefalse
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
GS100816271020711 [Primary]

FDA Product Code

HCCDevice, Biofeedback

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-15
Device Publish Date2023-06-07

On-Brand Devices [myoRESEARCH3 (MR3)]

00816271020797MR3 - myoPRESSURE
00816271020780MR3 - myoVIDEO
00816271020742MR3 - myoMOTION
00816271020711MR3 - myoMUSCLE

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