FDA.reportPublic FDA data

Handicare

Primary DI
00810045517582
Brand
Handicare
Company
HANDICARE USA, INC.
Model
5208A1200-S
Device description
Custom Universal Sling Polyslip - XL - No Hip Straps
Published
2025-08-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00810045517582PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810045517582008100455175828100455175820810045517582

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
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
00810045517513Handicare520547070-102024-10-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
05056387439426Rachel Harness Mesh Navy XXXSmallSILVALEA LIMITEDINE2024-08-05
05056387439433Rachel Harness Mesh Navy XXSmallSILVALEA LIMITEDINE2024-08-05
05056387439440Rachel Harness Mesh Navy Extra SmallSILVALEA LIMITEDINE2024-08-05
05056387439457Rachel Harness Mesh Navy SmallSILVALEA LIMITEDINE2024-08-05
05056387439464Rachel Harness Mesh Navy MediumSILVALEA LIMITEDINE2024-08-05
05056387439471Rachel Harness Mesh Navy LargeSILVALEA LIMITEDINE2024-08-05
05056387439488Rachel Harness Mesh Navy Extra LargeSILVALEA LIMITEDINE2024-08-05
05056387438900In-Situ Repositioning Sheet MediumSILVALEA LIMITEDINE2024-07-29
05056387438917In-Situ Repositioning Sheet LargeSILVALEA LIMITEDINE2024-07-29
05056387438924In-Situ Repositioning Sheet Extra LargeSILVALEA LIMITEDINE2024-07-29
05056387439372Stretcher Sling Mesh SmallSILVALEA LIMITEDINE2024-07-29
05056387439389Stretcher Sling Mesh MediumSILVALEA LIMITEDINE2024-07-29
05056387439396Stretcher Sling Mesh LargeSILVALEA LIMITEDINE2024-07-29
05056387439402Stretcher Sling Mesh Extra LargeSILVALEA LIMITEDINE2024-07-29
05056387415864Disposable High Easy LOOPS LargeSILVALEA LIMITEDINE2024-03-11
05056387415871Disposable High Easy Poly LOOPS LargeSILVALEA LIMITEDINE2024-03-11
05056387415888Disposable High Easy LOOPS MEDIUMSILVALEA LIMITEDINE2024-03-11
05056387415895Disposable High Easy Poly LOOPS MediumSILVALEA LIMITEDINE2024-03-11
05056387415901Disposable High Easy LOOPS SmallSILVALEA LIMITEDINE2024-03-11
05056387415918Disposable High Easy LOOPS Extra LargeSILVALEA LIMITEDINE2024-03-11
05056387415925Disposable High Easy LOOPS Extra SmallSILVALEA LIMITEDINE2024-03-11
05056387415932Disposable High Easy LOOPS XXLargeSILVALEA LIMITEDINE2024-03-11
05056387437040Repositioning Sheet Close Weave PolyesterSILVALEA LIMITEDINE2024-02-29
05056387403823General Stand Aid Sling D-A Clips White Extra LargeSILVALEA LIMITEDINE2024-02-28
05056387405148Birthing Sling ManualSILVALEA LIMITEDINE2024-02-28
05056387409245Stand Up Sling Clip Fixings LargeSILVALEA LIMITEDINE2024-02-28
05056387409252Stand Up Sling Loop Fixings LargeSILVALEA LIMITEDINE2024-02-28