FDA.reportPublic FDA data

Handi-Move Sling

Primary DI
05404016612021
Brand
Handi-Move Sling
Company
Handi-Move
Model
3494S 00000001
Catalog number
3494S 00000001
Device description
Amputationsling 3494S
Published
2020-09-08
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
05404016612021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05404016612021054040166120215404016612021

GMDN Terms#

Term, Definition table
TermDefinition
Patient lifting system amputee slingA lifting device used together with a patient lifting system to provide a support for an amputee that is being lifted in a sitting position with their body (back, arms, and buttocks) enveloped within the sling. It is typically designed as a U-shaped piece of strengthened fabric with lifting straps or eyes, a back support and seat and is constructed to tilt backwards enough to compensate for the lack of the counterweight of the users' amputated legs; this to ensure that the user does not tip forwards and fall out of the device. This is a reusable device.

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

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Primary DI, Brand, Company table
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