FDA.reportPublic FDA data

Kaye Products - SB1

Primary DI
00810117142940
Brand
Kaye Products - SB1
Company
Kaye Products, Inc.
Model
SB1
Device description
Scoot About
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
00810117142940PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810117142940008101171429408101171429400810117142940

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
08054040400612ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040400629ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040400636ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040400643ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040400650ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040400667ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402074ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402081ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402098ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402104ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402111ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402128ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402210ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402227ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402234ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402241ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402258ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402265ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402272ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402289ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402296ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402302ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402319ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402326ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402333ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402340ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402357ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402364ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402371ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402388ADJUSTABLE TROLLIORMESA SRLINM2026-09-06