Zhonglei

GUDID 06977100780009

Zhejiang Zhonglei Medical Technology Co.Ltd

Electric-motor-driven wheelchair, occupant-controlled
Primary Device ID06977100780009
NIH Device Record Key7f8d23e3-a0c4-4b26-851b-0632b18e9e25
Commercial Distribution StatusIn Commercial Distribution
Brand NameZhonglei
Version Model NumberPower wheelchair(N6101)
Company DUNS639611338
Company NameZhejiang Zhonglei Medical Technology Co.Ltd
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
GS106977100780009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITIWheelchair, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-09-19
Device Publish Date2024-09-11

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