FDA.report

Handicare

Primary DI
00810045510330
Brand
Handicare
Company
HANDICARE USA, INC.
Model
280079
Device description
Stand Aid Sling Belt - XL
Published
2020-08-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

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

Product Code Classifications

CodeDeviceSpecialtyClass
FSALift, Patient, Non-Ac-PoweredGeneral Hospital1
INESling, Overhead Suspension, WheelchairPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810045510330PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810045510330008100455103308100455103300810045510330

GMDN Terms

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

Regulatory Flags

DUNS number
800145836
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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00810045517575Handicare5204024552025-05-09
00810045517490Handicare520547050-102024-10-11
00810045517506Handicare520547060-102024-10-11
00810045517513Handicare520547070-102024-10-11
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00810045517483Handicare520517505-12024-09-24
00810045513553Handicare5208E4432-S-12020-11-16
00810045513836Handicare520280070-B-12020-11-16
00810045517476Handicare3609802024-05-10
00810045517445Handicare520537610-12023-10-26
00810045517421Handicare520547060-22023-10-23
00810045517438Handicare520547070-22023-10-23
00810045512761Handicare520517520-12023-07-11
00810045512754Handicare520547070-12023-05-01
00810045512693Handicare520580500-B2022-12-07
00810045512730Handicare5208A1300-S2022-12-07
00810045513072Handicare5208A1400-S2022-12-07

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05059441380474Arjo Loop Ambulatory SlingArjohuntleigh ABFSA2026-03-09
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10688503001808M-SERIESSavaria Concord LiftFSA2026-02-20
10688503001815M-SERIESSavaria Concord LiftFSA2026-02-20
00817956020224UltraLift - Tollos1073849 Ontario LimitedFSA2026-02-18
00860014768613LiftWalkINNOMOTIVE L.L.CFSA2026-02-04
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40080196764250MEDLINEMEDLINE INDUSTRIES, INC.FSA2026-01-27
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10688503001747M-SERIESSavaria Concord LiftFSA2026-01-26
10688503001754M-SERIESSavaria Concord LiftFSA2026-01-26
10688503001723M-SERIESSavaria Concord LiftFSA2026-01-15
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05059441295891Arjo Bariatric Loop SlingArjohuntleigh ABFSA2026-01-09
05059441295921Arjo Bariatric Loop SlingArjohuntleigh ABFSA2026-01-09
05059441295952Arjo Bariatric Loop SlingArjohuntleigh ABFSA2026-01-09
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