FDA.reportPublic FDA data

Karman Healthcare

Primary DI
00810058400185
Brand
Karman Healthcare
Company
KARMAN HEALTHCARE INC.
Model
R-4600-BL
Device description
R-4600 Lightweight Standard Rollator with Padded Seat and Backrest in Blue
Published
2022-10-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00810058400185PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810058400185008100584001858100584001850810058400185

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
878092667
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810058401601Karman HealthcareSLT-650HB2026-01-19
00810058401618Karman HealthcareSLT-6502026-01-19
00810058401588Karman Healthcare OT102024-06-28
00810058400321Karman Healthcare K2024-01-09
00810058400345Karman Healthcare M2024-01-09
00810058401571Karman Healthcare LT-5552024-01-09
00810058400123Karman Healthcare 802-DY2022-10-28
00810058400130Karman Healthcare 802N-DY2022-10-28
00810058401311Karman Healthcare LT-990-BK2022-10-28
00810058401328Karman Healthcare LT-980-BK2022-10-28
00810058401335Karman Healthcare LT-980-BD2022-10-28
00810058401342Karman Healthcare LT-980-SI2022-10-28
00810058401359Karman Healthcare KN-880-E2022-10-28
00810058401397Karman Healthcare LT-800T2022-10-28
00810058401403Karman Healthcare LT-700NT2022-10-28
00810058401410Karman Healthcare KN-700T2022-10-28
00810058401427Karman Healthcare KN-700NT2022-10-28
00810058401434Karman Healthcare LT-800NT2022-10-28
00810058401441Karman Healthcare LT-700T-20W2022-10-28
00810058401458Karman Healthcare LT-770Q2022-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06977176610248BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610255BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610262BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610279BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610286BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610293BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610309BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610316BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610323BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610330BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610347BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610354BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610361BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610378BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610385BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610392BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610408BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610415BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610422BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610439BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610446BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610453BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610460BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610477BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610484BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610491BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610507BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610514BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610521BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610538BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25