InMotion ARM

GUDID 00860001346701

BIONIK, INC.

Virtual-display rehabilitation system, powered-support Virtual-display rehabilitation system, powered-support, upper-limb Virtual-display rehabilitation system, powered-support, upper-limb Virtual-display rehabilitation system, powered-support, upper-limb Virtual-display rehabilitation system, powered-support, upper-limb Virtual-display rehabilitation system, powered-support, upper-limb Virtual-display rehabilitation system, powered-support, upper-limb Virtual-display rehabilitation system, powered-support, upper-limb Virtual-display rehabilitation system, powered-support, upper-limb Virtual-display rehabilitation system, powered-support, upper-limb Virtual-display rehabilitation system, powered-support, upper-limb Virtual-display rehabilitation system, powered-support, upper-limb
Primary Device ID00860001346701
NIH Device Record Key6490fa54-15d8-486e-9702-0f35a90841d4
Commercial Distribution StatusIn Commercial Distribution
Brand NameInMotion ARM
Version Model NumberSE4
Company DUNS080397777
Company NameBIONIK, 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 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
GS100860001346701 [Primary]

FDA Product Code

BXBExerciser, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-14
Device Publish Date2019-10-04

Devices Manufactured by BIONIK, INC.

00860001346701 - InMotion ARM2019-10-14
00860001346701 - InMotion ARM2019-10-14
00860001346718 - InMotion ARM/HAND2019-10-14

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