FDA.reportPublic FDA data

Handicare

Primary DI
00810045514819
Brand
Handicare
Company
HANDICARE USA, INC.
Model
600078
Device description
Small Disposable Belt
Published
2020-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
FSALift, Patient, Non-Ac-Powered
INESling, Overhead Suspension, Wheelchair

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSALift, Patient, Non-Ac-PoweredGeneral Hospital1
INESling, Overhead Suspension, WheelchairPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810045517070PackageGS110In Commercial Distribution
00810045514819PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810045517070008100455170708100455170700810045517070
00810045514819008100455148198100455148190810045514819

GMDN Terms#

Term, Definition table
TermDefinition
Stand-up mobile patient lifting system sling/harnessA lifting device used together with a stand-up mobile lift system to provide a support for an incapacitated patient or a person with a disability that is being lifted from a sitting to a standing position for transfer, (re)positioning and use of a toilet. It is also used to support the patient/person in a standing position to assist in dressing them. It is designed as a sling/harness construction made of straps which is strapped around the person's chest and which will cradle and hold their body during the lifting process. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
800145836
Device count
1
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
00810045517568Handicare520547080-102024-10-11
00810045517490Handicare520547050-102024-10-11
00810045517506Handicare520547060-102024-10-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10688503001877M-SERIESSavaria Concord LiftFSA2026-04-24
10688503001884M-SERIESSavaria Concord LiftFSA2026-04-24
10884389177624MEDLINEMEDLINE INDUSTRIES, INC.FSA2026-04-01
10884389196854MEDLINEMEDLINE INDUSTRIES, INC.FSA2026-04-01
10197344036653MEDLINEMEDLINE INDUSTRIES, INC.FSA2026-03-04
10197344170067MEDLINEMEDLINE INDUSTRIES, INC.FSA2025-11-07
10688503001662M-SERIESSavaria Concord LiftFSA2025-10-31
10688503001655M-SERIESSavaria Concord LiftFSA2025-10-30
10688503001624M-SERIESSavaria Concord LiftFSA2025-10-21
10688503001631M-SERIESSavaria Concord LiftFSA2025-10-21
10688503001648M-SERIESSavaria Concord LiftFSA2025-10-21
10688503001617M-SERIESSavaria Concord LiftFSA2025-10-20
10688503001594M-SERIESSavaria Concord LiftFSA2025-10-09
00816299012606HoverMatt PROS Hovertech InternationalFSA2025-09-10
00816299012613HoverMatt PROS Hovertech InternationalFSA2025-09-10
00816299012798HoverMatt PROS Hovertech InternationalFSA2025-09-10
10197344130245MEDLINEMEDLINE INDUSTRIES, INC.FSA2025-01-03
10197344129980MEDLINEMEDLINE INDUSTRIES, INC.FSA2024-12-19
10197344130078MEDLINEMEDLINE INDUSTRIES, INC.FSA2024-12-19
10884389120682MEDLINEMEDLINE INDUSTRIES, INC.FSA2024-12-10
00810045517537HandicareHANDICARE USA, INC.INE2024-10-11
00810045517544HandicareHANDICARE USA, INC.INE2024-10-11
00810045517551HandicareHANDICARE USA, INC.INE2024-10-11
00810045517568HandicareHANDICARE USA, INC.INE2024-10-11
10603354130323BAMEHOB INCFSA2024-09-03
10603354130347BAMEHOB INCFSA2024-09-03
10603354130361BAMEHOB INCFSA2024-09-03
07613327632873Sage TAP LCSAGE PRODUCTS, LLCFSA2024-03-26
07613327632880Sage TAP LCSAGE PRODUCTS, LLCFSA2024-03-26
10888277700147MedlineMEDLINE INDUSTRIES, INC.FSA2023-12-26