Upper Limb Rehabilitation Training System

GUDID 06979351820015

Shanghai ZDROID Medical Technology Co.,Ltd.

Virtual-display rehabilitation system, powered-support, upper-limb
Primary Device ID06979351820015
NIH Device Record Key3afe8479-fd7e-4f7f-ba87-b16999e87c1d
Commercial Distribution StatusIn Commercial Distribution
Brand NameUpper Limb Rehabilitation Training System
Version Model NumberAG01
Company DUNS415530495
Company NameShanghai ZDROID Medical Technology Co.,Ltd.
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
GS106979351820015 [Primary]

FDA Product Code

IKKSystem, Isokinetic Testing And Evaluation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06979351820015]

High-level Disinfectant


[06979351820015]

High-level Disinfectant


[06979351820015]

High-level Disinfectant


[06979351820015]

High-level Disinfectant


[06979351820015]

High-level Disinfectant


[06979351820015]

High-level Disinfectant


[06979351820015]

High-level Disinfectant


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-31
Device Publish Date2025-12-23

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