Walker R12-BK

by Zhongshan Sunneo Medical Instruments Co Ltd

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number06978305010052 UDI-DI	Date17 Nov 2025Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Walker
Generic Name: Handgrip disability-assistive walker, non-powered, non-foldable
Model / Reference: R12-BK

Primary DI / UDI-DI: 06978305010052
FDA Product Code: ITJ
GMDN Term: Handgrip disability-assistive walker, non-powered, non-foldable

Device Class: Class I
Regulation Number: 890.3825
GUDID distribution status: In Commercial Distribution

Other devices from Zhongshan Sunneo Medical Instruments Co Ltd

Walker R11-BK

Class I
Walker R11-CP

Class I
Walker R11-PU

Class I
Walker R12-CP

Class I
Walker R11-RD

Class I
Walker R12-RD

Class I

See all devices from Zhongshan Sunneo Medical Instruments Co Ltd →

Properties

Over-the-Counter
Premarket Exempt
Lot / Batch Number
Manufacturing Date

Other properties (10)

Sterile: No
Single Use: No
Implantable: No
Contains Latex: No
Prescription Use: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Serial Number: No
Expiration Date: No