FDA.reportPublic FDA data

Kaye Products - W2H

Primary DI
00810117143442
Brand
Kaye Products - W2H
Company
Kaye Products, Inc.
Model
W2H
Device description
Youth Posture Control Walker/Gait Trainer/2 Wheels
Published
2023-07-05
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
00810117143442PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810117143442008101171434428101171434420810117143442

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

Regulatory Flags#

DUNS number
082364654
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810117140007Kaye Products, W1/2BW1/2B2023-07-05
00810117140014Kaye Products - W1/2BRW1/2BR2023-07-05
00810117140021Kaye Products - W1/2BSW1/2BS2023-07-05
00810117140076Kaye Products - W1/2BRXW1/2BRX2023-07-05
00810117140083Kaye Products - W1/2BSXW1/2BSX2023-07-05
00810117140090Kaye Products - W1BW1B2023-07-05
00810117140106Kaye Products - W1BRW1BR2023-07-05
00810117140113Kaye Products - W1BSW1BS2023-07-05
00810117140168Kaye Products - W1BRXW1BRX2023-07-05
00810117140175Kaye Products - W1BSXW1BSX2023-07-05
00810117140182Kaye Products - W2BW2B2023-07-05
00810117140199Kaye Products - W2BRW2BR2023-07-05
00810117140205Kaye Products - W2BSW2BS2023-07-05
00810117140250Kaye Products - W2BRXW2BRX2023-07-05
00810117140267Kaye Products - W2BSXW2BSX2023-07-05
00810117140274Kaye Products - W3BW3B2023-07-05
00810117140281Kaye Products - W3BRW3BR2023-07-05
00810117140298Kaye Products - W3BSW3BS2023-07-05
00810117140342Kaye Products - W3BRXW3BRX2023-07-05
00810117140359Kaye Products - W3BSXW3BSX2023-07-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00810178885022Vive MobilityVIVE HEALTH LLCITJ2026-04-27
00810178885039Vive MobilityVIVE HEALTH LLCITJ2026-04-27
00810178885046Vive MobilityVIVE HEALTH LLCITJ2026-04-27
00810178885053Vive MobilityVIVE HEALTH LLCITJ2026-04-27
00810178885060Vive MobilityVIVE HEALTH LLCITJ2026-04-27
00810178885077Vive MobilityVIVE HEALTH LLCITJ2026-04-27
00810178885619Vive MobilityVIVE HEALTH LLCITJ2026-04-27
00810178887347Vive MobilityVIVE HEALTH LLCITJ2026-04-27
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
00815027011867DALTON ROLLATOR DALTON MEDICAL CORPORATIONITJ2025-10-28
00815027011881DALTON ROLLATOR DALTON MEDICAL CORPORATIONITJ2025-10-28
00815027012888DALTON ROLLATOR DALTON MEDICAL CORPORATIONITJ2025-10-28
B845X1021WOTUREIntco Medical Industries, Inc.ITJ2025-08-20
B845X3011WOTUREIntco Medical Industries, Inc.ITJ2025-06-13