FDA.reportPublic FDA data

"Handi-Move Mobile Lift ""16xx"""

Primary DI
05404016610218
Brand
"Handi-Move Mobile Lift ""16xx"""
Company
Handi-Move
Model
1635 00000001
Catalog number
1635 00000001
Device description
Mobile hoist 1635
Published
2021-08-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
05404016610218PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05404016610218054040166102185404016610218

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

Contacts#

Phone, Email table
PhoneEmail
+1(800) 724-5305info@surehands.com

Regulatory Flags#

DUNS number
283658730
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05404016613899Handi-Move Sling3489L000000013489L 000000012026-06-02
05404016613905Handi-Move Sling3489L 900000013489L 900000012026-06-02
05404016613974Handi-Move Sling3440XS 900000013440XS 900000012026-06-02
05404016613981Handi-Move Sling3440S 900000013440S 900000012026-06-02
05404016613998Handi-Move Sling3440M 900000013440M 900000012026-06-02
05404016614001Handi-Move Sling3440L 900000013440L 900000012026-06-02
05404016614018Handi-Move Sling3440XL 900000013440XL 900000012026-06-02
05404016613646Handi-Move Sling3552XS 900000013552XS 900000012024-07-10
05404016613653Handi-Move Sling3552S 900000013552S 900000012024-07-10
05404016613462Handi-Move Portable Motor2840 000000012840 000000012023-08-10
05404016613479Handi-Move Portable Motor2845 000000012845 000000012023-03-30
05404016613516Handi-Move Sling3550XS 000000013550XS 000000012023-03-30
05404016613523Handi-Move Sling3550S 000000013550S 000000012023-03-30
05404016613530Handi-Move Sling3551XS 000000013551XS 000000012023-03-30
05404016613547Handi-Move Sling3551S 000000013551S 000000012023-03-30
05404016613554Handi-Move Sling3552XS 000000013552XS 000000012023-03-30
05404016613561Handi-Move Sling3552S 000000013552S 000000012023-03-30
05404016613578Handi-Move Sling3553XS 000000013553XS 000000012023-03-30
05404016613585Handi-Move Sling3553S 000000013553S 000000012023-03-30
05404016612052Handi-Move Sling3497 900000013497 900000012020-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06975084500101CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
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06975084500132CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
06975084500149CostcareXIAMEN ATLANTIS MFC CO.,LTDFSA2026-09-24
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