FDA.reportPublic FDA data

Handicare

Primary DI
00810045517568
Brand
Handicare
Company
HANDICARE USA, INC.
Model
520547080-10
Device description
Custom Disposable Universal Sling w_HS - XL (Case 10)
Published
2024-10-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
INESling, Overhead Suspension, Wheelchair

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
INESling, Overhead Suspension, WheelchairPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810045517568PrimaryGS10
00810045517520Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810045517568008100455175688100455175680810045517568
00810045517520008100455175208100455175200810045517520

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose patient lifting system sling/harnessA general-purpose lifting device used together with a patient lifting system to provide a support for an incapacitated patient or a person with a disability that is being lifted in a sitting position with their body (back, arms, buttocks and upper legs) held within the sling for transfer and (re)positioning. It is typcially constructed of straps, belts and material in which the occupant is cradled and contained during the lifting process; some types may employ additional straps, belts or vest-like harnesses to safely secure the occupant within the device. It typically has lifting straps or eyes that attach to a two-point, three-point or four-point spreader bar. This is a reusable device.

Regulatory Flags#

DUNS number
800145836
Device count
10
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810045517582Handicare5208A1200-S2025-08-13
00810045517599Handicare5208A1500-S2025-08-13
00810045517605Handicare5208A1600-S2025-08-13
00810045512785Handicare3030802020-12-14
00810045510040Handicare3030702020-07-02
00810045510385Handicare3030602020-07-02
00810045510392Handicare3030732020-07-02
00810045510408Handicare3030752020-07-02
00810045510415Handicare3030772020-07-02
00810045510422Handicare3030902020-07-02
00810045510439Handicare3030912020-07-02
00810045510446Handicare3030932020-07-02
00810045512808Handicare3030742020-07-02
00810045517575Handicare5204024552025-05-09
00810045517537Handicare520547050-102024-10-11
00810045517544Handicare520547060-102024-10-11
00810045517551Handicare520547070-102024-10-11
00810045517490Handicare520547050-102024-10-11
00810045517506Handicare520547060-102024-10-11
00810045517513Handicare520547070-102024-10-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810045517582HandicareHANDICARE USA, INC.INE2025-08-13
00810045517599HandicareHANDICARE USA, INC.INE2025-08-13
00810045517605HandicareHANDICARE USA, INC.INE2025-08-13
00810045517575HandicareHANDICARE USA, INC.INE2025-05-09
05056387401836Silvalea Boned Back Stand aid poly loops LARGESILVALEA LIMITEDINE2025-03-13
05056387401850Silvalea Boned Back Stand aid poly loops MEDIUMSILVALEA LIMITEDINE2025-03-13
05056387401898Silvalea Boned Back Stand aid poly loops EXTRA LARGESILVALEA LIMITEDINE2025-03-13
00810045517537HandicareHANDICARE USA, INC.INE2024-10-11
00810045517544HandicareHANDICARE USA, INC.INE2024-10-11
00810045517551HandicareHANDICARE USA, INC.INE2024-10-11
00810045517490HandicareHANDICARE USA, INC.INE2024-10-11
00810045517506HandicareHANDICARE USA, INC.INE2024-10-11
00810045517513HandicareHANDICARE USA, INC.INE2024-10-11
00810045517520HandicareHANDICARE USA, INC.INE2024-10-11
00810045517483HandicareHANDICARE USA, INC.INE2024-09-24
07898493080073Skin Cooler Roller - LARGE (white)FABINJECT INDUSTRIA E COMERCIO IMPORTACAO E EXPORTACAO LTDAINE2024-06-14
07898493080080Skin Cooler Roller - LARGE (lilac)FABINJECT INDUSTRIA E COMERCIO IMPORTACAO E EXPORTACAO LTDAINE2024-06-14
07898493080097Skin Cooler Roller - LARGE (blue)FABINJECT INDUSTRIA E COMERCIO IMPORTACAO E EXPORTACAO LTDAINE2024-06-14
07898493080103Skin Cooler Roller - LARGE (green)FABINJECT INDUSTRIA E COMERCIO IMPORTACAO E EXPORTACAO LTDAINE2024-06-14
07898493080141Skin Cooler Roller - SMALL (green)FABINJECT INDUSTRIA E COMERCIO IMPORTACAO E EXPORTACAO LTDAINE2024-06-14
05060405746144BananaGBUK LTDINE2024-01-22
05060405746151BananaGBUK LTDINE2024-01-22
05060405746168BananaGBUK LTDINE2024-01-22
05060405746175BananaGBUK LTDINE2024-01-22
05060405746182BananaGBUK LTDINE2024-01-22
05060405746199BananaGBUK LTDINE2024-01-22
05060405746205BananaGBUK LTDINE2024-01-22
05060405746212BananaGBUK LTDINE2024-01-22
05060405746229BananaGBUK LTDINE2024-01-22
05060405746236BananaGBUK LTDINE2024-01-22