Rollator

GUDID 06978305011004

ZHONGSHAN SUNNEO MEDICAL INSTRUMENTS CO LTD

Handgrip disability-assistive walker, non-powered, non-foldable
Primary Device ID06978305011004
NIH Device Record Keye82aabd6-6a71-41ad-911e-b7420040360d
Commercial Distribution StatusIn Commercial Distribution
Brand NameRollator
Version Model NumberDR9222-A
Company DUNS617880669
Company NameZHONGSHAN SUNNEO MEDICAL INSTRUMENTS 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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS106978305011004 [Primary]

FDA Product Code

ITJWalker, Mechanical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-11-25
Device Publish Date2025-11-17

On-Brand Devices [Rollator]

06978305011011DR9246
06978305011004DR9222-A
06978305010991DR9248

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.