FDA.reportPublic FDA data

Handicare

Primary DI
00810045513751
Brand
Handicare
Company
HANDICARE USA, INC.
Model
400104
Device description
Extra Large Sheepskin Cover
Published
2020-08-28
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
00810045513751PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810045513751008100455137518100455137510810045513751

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
00810045517612Handicare520517340-12026-06-10
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10688503002058M-SERIESSavaria Concord LiftFSA2026-07-16
10688503001938M-SERIESSavaria Concord LiftFSA2026-06-22
00810045517612HandicareHANDICARE USA, INC.INE2026-06-10
05600494139948Invacare Birdie Evo XPlus Full Body LiftINVACARE CORPORATIONFSA2026-06-03
05404016613813Handi-Move SlingHandi-MoveFSA2026-06-02
05404016613820Handi-Move SlingHandi-MoveFSA2026-06-02
05404016613837Handi-Move SlingHandi-MoveFSA2026-06-02
05404016613844Handi-Move SlingHandi-MoveFSA2026-06-02
05404016613851Handi-Move SlingHandi-MoveFSA2026-06-02
05404016613868Handi-Move SlingHandi-MoveFSA2026-06-02
05404016613875Handi-Move SlingHandi-MoveFSA2026-06-02
05404016613882Handi-Move SlingHandi-MoveFSA2026-06-02
05404016613899Handi-Move SlingHandi-MoveFSA2026-06-02
05404016613905Handi-Move SlingHandi-MoveFSA2026-06-02
05404016613912Handi-Move SpreaderbarHandi-MoveFSA2026-06-02
05404016613929Handi-Move SpreaderbarHandi-MoveFSA2026-06-02
05404016613936Handi-Move SpreaderbarHandi-MoveFSA2026-06-02
05404016613943Handi-Move SlingHandi-MoveFSA2026-06-02
05404016613950Handi-Move SlingHandi-MoveFSA2026-06-02
05404016613967Handi-Move SlingHandi-MoveFSA2026-06-02
05404016613974Handi-Move SlingHandi-MoveFSA2026-06-02
05404016613981Handi-Move SlingHandi-MoveFSA2026-06-02
05404016613998Handi-Move SlingHandi-MoveFSA2026-06-02
05404016614001Handi-Move SlingHandi-MoveFSA2026-06-02
05404016614018Handi-Move SlingHandi-MoveFSA2026-06-02
05404016614025Handi-Move SlingHandi-MoveFSA2026-06-02
05404016614032Handi-Move SlingHandi-MoveFSA2026-06-02
10688503001860M-SERIESSavaria Concord LiftFSA2026-03-19
05056387401836Silvalea Boned Back Stand aid poly loops LARGESILVALEA LIMITEDINE2025-03-13
05056387401850Silvalea Boned Back Stand aid poly loops MEDIUMSILVALEA LIMITEDINE2025-03-13