FDA.reportPublic FDA data

Handicare

Primary DI
00810045512532
Brand
Handicare
Company
HANDICARE USA, INC.
Model
450013
Device description
Low Profile 600 lb. Lift w/Scale
Published
2020-09-16
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

Product Codes#

Code, Name table
CodeName
FSALift, Patient, Non-Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSALift, Patient, Non-Ac-PoweredGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810045512532PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810045512532008100455125328100455125320810045512532

GMDN Terms#

Term, Definition table
TermDefinition
Mobile patient lifting system, battery-poweredA battery-powered, mobile assembly of devices designed to enable one person to lift and move an incapacitated patient or a person with a disability, of any size and weight, safely and with minimal physical effort. Also known as a patient hoist, it typically consists of a support base on wheels with a motorized lifting mechanism, mast, boom/lifting arm(s), swivel bar, a patient holding device (e.g., a sling, holder or a frame), and a rechargeable battery. It is typically used to lift and move the occupant in a sitting or semi-sitting position over short distances within the treatment facility, e.g., from a bed to a bathroom.

Sterilization Methods#

Method table
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
true
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810045517582Handicare5208A1200-S2025-08-13
00810045517599Handicare5208A1500-S2025-08-13
00810045517605Handicare5208A1600-S2025-08-13
00810045517575Handicare5204024552025-05-09
00810045517490Handicare520547050-102024-10-11
00810045517506Handicare520547060-102024-10-11
00810045517513Handicare520547070-102024-10-11
00810045517520Handicare520547080-102024-10-11
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10688503001860M-SERIESSavaria Concord LiftFSA2026-03-19
10688503001853M-SERIESSavaria Concord LiftFSA2026-03-12
05059441380450Arjo Loop Ambulatory SlingArjohuntleigh ABFSA2026-03-09
05059441380467Arjo Loop Ambulatory SlingArjohuntleigh ABFSA2026-03-09
05059441380474Arjo Loop Ambulatory SlingArjohuntleigh ABFSA2026-03-09
05059441380481Arjo Loop Ambulatory SlingArjohuntleigh ABFSA2026-03-09
20197344036650MEDLINEMEDLINE INDUSTRIES, INC.FSA2026-03-04
10688503001839M-SERIESSavaria Concord LiftFSA2026-03-04
10688503001846M-SERIESSavaria Concord LiftFSA2026-03-04
10688503001778M-SERIESSavaria Concord LiftFSA2026-02-20
10688503001785M-SERIESSavaria Concord LiftFSA2026-02-20
10688503001792M-SERIESSavaria Concord LiftFSA2026-02-20
10688503001808M-SERIESSavaria Concord LiftFSA2026-02-20
10688503001815M-SERIESSavaria Concord LiftFSA2026-02-20
00817956020224UltraLift - Tollos1073849 Ontario LimitedFSA2026-02-18
00860014768613LiftWalkINNOMOTIVE L.L.CFSA2026-02-04
00860014768668LiftWalkINNOMOTIVE L.L.CFSA2026-02-04
10688503001761M-SERIESSavaria Concord LiftFSA2026-01-28
40080196764250MEDLINEMEDLINE INDUSTRIES, INC.FSA2026-01-27
40884389144825MEDLINEMEDLINE INDUSTRIES, INC.FSA2026-01-27
10688503001730M-SERIESSavaria Concord LiftFSA2026-01-26
10688503001747M-SERIESSavaria Concord LiftFSA2026-01-26
10688503001754M-SERIESSavaria Concord LiftFSA2026-01-26
10688503001723M-SERIESSavaria Concord LiftFSA2026-01-15
05059441295860Arjo Bariatric Loop SlingArjohuntleigh ABFSA2026-01-09
05059441295891Arjo Bariatric Loop SlingArjohuntleigh ABFSA2026-01-09
05059441295921Arjo Bariatric Loop SlingArjohuntleigh ABFSA2026-01-09
05059441295952Arjo Bariatric Loop SlingArjohuntleigh ABFSA2026-01-09
00860014621871ValmaxSupply Line MedicalFSA2025-12-22
10688503001716M-SERIESSavaria Concord LiftFSA2025-12-12