InMotion ARM/HAND

GUDID 00860001346718

BIONIK, INC.

Virtual-display rehabilitation system, powered-support
Primary Device ID00860001346718
NIH Device Record Key72ed7105-19ee-4e2d-b7cd-5f758322e7ff
Commercial Distribution StatusIn Commercial Distribution
Brand NameInMotion ARM/HAND
Version Model NumberSE4HA4
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
GS100860001346718 [Primary]

FDA Product Code

IKKSystem, Isokinetic Testing And Evaluation

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

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