FDA.report

Handicare

Primary DI
00810045512624
Brand
Handicare
Company
HANDICARE USA, INC.
Model
329104
Device description
C1000 Manual Traverse-Quick Curve
Published
2020-07-13
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

Product Code Classifications

CodeDeviceSpecialtyClass
FSALift, Patient, Non-Ac-PoweredGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810045512624PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810045512624008100455126248100455126240810045512624

GMDN Terms

TermDefinition
Overhead track patient lifting/transfer systemA electrically-powered assembly of devices designed to enable an incapacitated patient or a person with a disability to be lifted/moved (transferred) safely and with minimal physical effort within the confines of one floor of a building, typically an institution or the person's home. It typically consists of ceiling-mounted track, and a motorized hoist and patient holding device (e.g., a sling, holder or a frame) for lifting and lowering the patient, that can be moved along the overhead track.

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
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

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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

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05059441380481Arjo Loop Ambulatory SlingArjohuntleigh ABFSA2026-03-09
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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
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10688503001761M-SERIESSavaria Concord LiftFSA2026-01-28
40080196764250MEDLINEMEDLINE INDUSTRIES, INC.FSA2026-01-27
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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