FDA.reportPublic FDA data

Kaye Products - SBAO

Primary DI
00810117142957
Brand
Kaye Products - SBAO
Company
Kaye Products, Inc.
Model
SBAO
Device description
Optional Back Support for Scoot About (SB1)
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
INMChair, With Casters

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
INMChair, With CastersPhysical Medicine1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K924848000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K924848000KAYE SCOOT-ABOUT, MODEL SB1Kaye Products, Inc.1993-02-12INM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810117142957PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810117142957008101171429578101171429570810117142957

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose stool/chairA seat, usually height-adjustable, intended to be occupied by staff or patients during medical procedures, examinations, or rest; it may include support for the back, arms and feet (footrest/ring). It is not dedicated to a specific clinical specialty, procedure, or location. It may be used in a healthcare facility, office, or in the home.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
082364654
Device count
1

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
08054040402135BUGORMESA SRLINM2026-08-01
08054040402142BUGORMESA SRLINM2026-08-01
08055715702949BUGORMESA SRLINM2026-08-01
08055715702956BUGORMESA SRLINM2026-08-01
08055715702963BUGORMESA SRLINM2026-08-01
08055715702970BUGORMESA SRLINM2026-08-01
08055715703021BUGORMESA SRLINM2026-08-01
08055715703038BUGORMESA SRLINM2026-08-01
08055715703045BUGORMESA SRLINM2026-08-01
08055715703052BUGORMESA SRLINM2026-08-01
08055715703106BUGORMESA SRLINM2026-08-01
08055715703113BUGORMESA SRLINM2026-08-01
08055715703120BUGORMESA SRLINM2026-08-01
08055715703137BUGORMESA SRLINM2026-08-01
08055715703182BUGORMESA SRLINM2026-08-01
08055715703199BUGORMESA SRLINM2026-08-01
08055715703205BUGORMESA SRLINM2026-08-01
08055715703212BUGORMESA SRLINM2026-08-01
06973717271602GARVEEFoshan Dahao Medical Technology Co., Ltd.INM2026-07-29
06973717271633GARVEEFoshan Dahao Medical Technology Co., Ltd.INM2026-07-29
06973717272104GARVEEFoshan Dahao Medical Technology Co., Ltd.INM2026-07-29
06973717276836GARVEEFoshan Dahao Medical Technology Co., Ltd.INM2026-07-29
06973717276843GARVEEFoshan Dahao Medical Technology Co., Ltd.INM2026-07-29
06973717276881GARVEEFoshan Dahao Medical Technology Co., Ltd.INM2026-07-29
06973717276829VerpalFoshan Dahao Medical Technology Co., Ltd.INM2026-06-06
00840117408739ConvaidCONVAID PRODUCTS, INC.INM2026-04-10
00840117408746ConvaidCONVAID PRODUCTS, INC.INM2026-04-10
00840117408753ConvaidCONVAID PRODUCTS, INC.INM2026-04-10
00840117408760ConvaidCONVAID PRODUCTS, INC.INM2026-04-10
00840117408777ConvaidCONVAID PRODUCTS, INC.INM2026-04-10