ZYGENAIR

GUDID 06974665662979

Yongkang Youha Electric Appliance Co.,Ltd

Electric-motor-driven wheelchair, occupant-controlled
Primary Device ID06974665662979
NIH Device Record Keye20c482e-03ab-4067-bc91-9194bfb4a787
Commercial Distribution StatusIn Commercial Distribution
Brand NameZYGENAIR
Version Model NumberYHWL002
Company DUNS541069715
Company NameYongkang Youha Electric Appliance 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 Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106974665662979 [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 Date2025-05-27
Device Publish Date2025-05-19

On-Brand Devices [ZYGENAIR]

06974665663402YHW001-F
06974665662979YHWL002
06974665668834YHW001-D
06974665669138YHWL003
06974665669060YHW001-C

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