FDA.reportPublic FDA data

Handicare

Primary DI
00810045516622
Brand
Handicare
Company
HANDICARE USA, INC.
Model
8H4600
Device description
DELUXE HAMMOCK-SPACER-XS
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
00810045516622PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810045516622008100455166228100455166220810045516622

GMDN Terms#

Term, Definition table
TermDefinition
Patient lifting system hammock slingA 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 or semi-recumbent position with their body (back, head, arms, buttocks and upper legs) enveloped within the sling. It is typically designed as a rectangular piece of strengthened fabric with lifting straps or eyes; it may be with or without a commode aperture. This type of sling disperses the body weight over a large area of material reducing the likelihood of pressure sores; no user cooperation is required. 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
10688503002058M-SERIESSavaria Concord LiftFSA2026-07-16
10688503001938M-SERIESSavaria Concord LiftFSA2026-06-22
00810045517612HandicareHANDICARE USA, INC.INE2026-06-10
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
10688503001860M-SERIESSavaria Concord LiftFSA2026-03-19
05056387401836Silvalea Boned Back Stand aid poly loops LARGESILVALEA LIMITEDINE2025-03-13
05056387401850Silvalea Boned Back Stand aid poly loops MEDIUMSILVALEA LIMITEDINE2025-03-13