FDA.reportPublic FDA data

Handicare

Primary DI
00810045512457
Brand
Handicare
Company
HANDICARE USA, INC.
Model
402515
Device description
Bariatric Walking 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
00810045512457PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810045512457008100455124578100455124570810045512457

GMDN Terms#

Term, Definition table
TermDefinition
Patient lifting system lift pantsA lifting device used together with a mobile lift system (normally a ceiling-mounted overhead track system) to provide a support for an incapacitated patient or a person with a disability that has been raised from a sitting position and held in a standing position for mobility training; it is primarily used for confidence building when walking. It is designed as a sling construction made of straps attached to a pants-like holder which is placed between the users' legs (the crotch) and secured high around the waist which will cradle the hip section of their body allowing them to maintain balance whilst moving slowly forward using their feet. 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
10688503002218M-SERIESSavaria Concord LiftFSA2026-10-06
10193489003086MEDLINEMEDLINE INDUSTRIES, INC.FSA2026-09-29
10888277658332MEDLINEMEDLINE INDUSTRIES, INC.FSA2026-09-29
06972077023135CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06972077023722CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06972077023739CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06972077023814CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06972077024033CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06972077025092CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06975084500101CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06975084500118CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06975084500125CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06975084500132CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06975084500149CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06975084500156CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06975084500163CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06975084500170CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06975084500187CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06975084500194CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06975084500200CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06975084500217CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06975084500224CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06975084500231CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06975084500248CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06975084500255CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06975084500262CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06975084500279CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06975084500286CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06972077023128CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-19
10688503002195M-SERIESSavaria Concord LiftFSA2026-09-18