FDA.reportPublic FDA data

Handicare

Primary DI
00810045512488
Brand
Handicare
Company
HANDICARE USA, INC.
Model
450001
Device description
Low Profile Lift
Published
2020-09-16
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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810045512488PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810045512488008100455124888100455124880810045512488

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
Premarket exempt
true
Serial number
true
Manufacturing date on label
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
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
10688503001877M-SERIESSavaria Concord LiftFSA2026-04-24
10688503001884M-SERIESSavaria Concord LiftFSA2026-04-24
10884389177624MEDLINEMEDLINE INDUSTRIES, INC.FSA2026-04-01
10884389196854MEDLINEMEDLINE INDUSTRIES, INC.FSA2026-04-01