FDA.reportPublic FDA data

Sharper Image

Primary DI
00840397513574
Brand
Sharper Image
Company
Merchsource, LLC
Model
1019377
Published
2025-05-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ITJWalker, Mechanical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITJWalker, MechanicalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840397513574PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840397513574008403975135748403975135740840397513574

GMDN Terms#

Term, Definition table
TermDefinition
Handgrip disability-assistive walker, non-powered, foldableA non-powered, all- or partially-wheeled mobility aid in the form of a waist-high, foldable framework with handgrips and three or four legs designed to provide a stable support for a patient with a walking disability, a geriatric, obese, or infirm patient when standing or ambulating; it may also be used during rehabilitation. It is constructed of lightweight metal, plastic, and rubber materials and in the form of a mobile support structure which the patient holds and pushes in front of them as they walk. It is foldable for storage and transportation and may include a braking mechanism; it may be width-adjustable and some types may include a seat on which the patient can rest.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18003742744isupport@merchsource.com

Regulatory Flags#

DUNS number
121820737
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840397513352Sharper Image10193572026-06-28
00840397513215Sharper Image10193412026-04-23
00840397513284Sharper Image10193482026-02-17
00840397501151Sharper Image10180182025-09-22
00840397503223Sharper Image10182392025-09-22
00840397517961Sharper Image10198522025-06-06
00843479127003Sharper Image10126542025-01-01
00843479157772Sharper Image10149632024-08-03
00843479107487Sharper Image10118522024-06-01
00843479107494Sharper Image10118532024-06-01
00843479107500Sharper Image10118542024-06-01
00843479108552Sharper Image1012070,1012654, 10171912024-06-01
00843479124149Sharper Image10122872024-06-01
00843479126259Sharper Image10125492024-06-01
00843479137637Sharper Image10135392024-06-01
00843479157758Sharper Image10149612024-06-01
00843479159653Sharper Image10152432024-06-01
00843479166262Sharper Image1016761, 10153522024-06-01
00843479185256Sharper Image10173392024-06-01
00843479198263Sharper Image10107662024-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860001638721PerfectFit Standard RollatorCarrier Medical LLCITJ2026-07-13
00860001638783PerfectFit Heavy Duty RollatorCarrier Medical LLCITJ2026-07-13
00860001638790Phantom Knee WalkerCarrier Medical LLCITJ2026-07-13
00860014392702ICON Heavy Duty RollatorCarrier Medical LLCITJ2026-07-13
00860014392719ICON Standard RollatorCarrier Medical LLCITJ2026-07-13
00860014392726AirLite Standard RollatorCarrier Medical LLCITJ2026-07-13
04719876190253TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.ITJ2026-07-08
00194346283439EquateDrive Devilbiss HealthcareITJ2026-06-10
00199536930186BluelineTransparent Supply Solutions Ltd.ITJ2026-05-15
00199536930193BluelineTransparent Supply Solutions Ltd.ITJ2026-05-15
00199536930209BluelineTransparent Supply Solutions Ltd.ITJ2026-05-15
00199536930216BluelineTransparent Supply Solutions Ltd.ITJ2026-05-15
00199536930223BluelineTransparent Supply Solutions Ltd.ITJ2026-05-15
14895262504259SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
14895262504266SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
14895262504273SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
14895262504280SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
14895262504693HOMLANDHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
14895262504709HOMLANDHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
14895262504716HOMLANDHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
14895262504730HOMLANDHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
24895262504324SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
54895262504226HOMLANDHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
54895262504233HOMLANDHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
54895262504240HOMLANDHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
08054040402432GRILLOORMESA SRLITJ2025-09-15
08054040402449GRILLOORMESA SRLITJ2025-09-15
08054040402463GRILLOORMESA SRLITJ2025-09-15
08054040402470GRILLOORMESA SRLITJ2025-09-15
08054040402487GRILLOORMESA SRLITJ2025-09-15