FDA.reportPublic FDA data

Handicare

Primary DI
00810045511924
Brand
Handicare
Company
HANDICARE USA, INC.
Model
400022
Device description
Large Care Sling
Published
2020-08-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00810045511924PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810045511924008100455119248100455119240810045511924

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
800145836
Device count
1
Premarket exempt
true
Serial number
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