FDA.reportPublic FDA data

Kaye Products - DS4

Primary DI
00810117142766
Brand
Kaye Products - DS4
Company
Kaye Products, Inc.
Model
DS4
Device description
Large Dynamic Stander
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
ILTAdaptor, Recreational

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILTAdaptor, RecreationalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810117142766PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810117142766008101171427668101171427660810117142766

GMDN Terms#

Term, Definition table
TermDefinition
Manual stander/exerciserA manually-powered device designed to support and lift a disabled (paraplegic) patient to an upright standing position, and to enable the occupant to perform an exercise, to provide the health benefits associated with standing/exercising; it is neither intended to facilitate gait, provide patient mobility, nor assist standing transfer. It typically consists of a seat and/or platform with appropriate supports (e.g., footplates, kneepads, chest pad), an exercise mechanism (e.g., moveable handles with reciprocal leg movement), and a manual mechanical lifting mechanism; the patient is raised from a supine and/or seated position by themselves or with the assistance of a healthcare provider.

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
04262429651096Lumo Hold O-2macu4 GmbHILT2026-07-18
04262429651102Lynk Hold Lock O-2macu4 GmbHILT2026-07-18
04262429650204Lynk Hook Module standardmacu4 GmbHILT2025-11-23
04262429650211Lynk Push Module standardmacu4 GmbHILT2025-11-23
04262429650228Lynk Hold STD Modulemacu4 GmbHILT2025-11-23
04262429650235Lynk Clic Modulemacu4 GmbHILT2025-11-23
04262429650242Lynk Clic Head 360°macu4 GmbHILT2025-11-23
04262429650259Lynk Clic Head 70°macu4 GmbHILT2025-11-23
04262429650266Lynk Clic Head 0°macu4 GmbHILT2025-11-23
04262429650273Lynk Clic Adaptermacu4 GmbHILT2025-11-23
04262429650327Lynk Clic Lock Modulemacu4 GmbHILT2025-11-23
04262429650334Lynk Clic Lock Head 360°, STDmacu4 GmbHILT2025-11-23
04262429650341Lynk Clic Lock Head 70°, STDmacu4 GmbHILT2025-11-23
04262429650358Lynk Clic Lock Head 0°, STDmacu4 GmbHILT2025-11-23
04262429650365Lynk Clic Lock Adaptermacu4 GmbHILT2025-11-23
04262429650372Lynk Hold Lock Modulemacu4 GmbHILT2025-11-23
04262429650389Lumo Cuff, STD-SML-Amacu4 GmbHILT2025-11-23
04262429650396Lumo Shovel, STDmacu4 GmbHILT2025-11-23
04262429650402Lumo Hold, Lockmacu4 GmbHILT2025-11-23
04262429650419Lumo Roll, STDmacu4 GmbHILT2025-11-23
04262429650426Lumo Clamp, STDmacu4 GmbHILT2025-11-23
04262429650433Lynk Clic Lock Head 70°, ELLIPSEmacu4 GmbHILT2025-11-23
04262429650440Lynk Clic Lock Head 0°, ELLIPSEmacu4 GmbHILT2025-11-23
04262429650457Lynk Clic Lock Head 360°, ELLIPSEmacu4 GmbHILT2025-11-23
04262429650464Lynk Clic Lock Head 70°, FLATmacu4 GmbHILT2025-11-23
04262429650471Lynk Clic Lock Head 360°, FLATmacu4 GmbHILT2025-11-23
04262429650488Lynk Clic Lock Head 0°, FLATmacu4 GmbHILT2025-11-23
04262429650495Lumo Cuff, STD-SML-Bmacu4 GmbHILT2025-11-23
04262429650501Lumo Cuff, STD-SML-Cmacu4 GmbHILT2025-11-23
04262429650518Lumo Cuff, STD-SML-Dmacu4 GmbHILT2025-11-23