FDA.report

Walking Sling Large

Primary DI
05056387415819
Brand
Walking Sling Large
Company
SILVALEA LIMITED
Model
M921503-L
Published
2024-02-26
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
INESling, Overhead Suspension, Wheelchair

Product Code Classifications

CodeDeviceSpecialtyClass
INESling, Overhead Suspension, WheelchairPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05056387415819PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05056387415819050563874158195056387415819

GMDN Terms

TermDefinition
Patient lifting system lift pantsA lifting device used together with a mobile lift system (normally a ceiling-mounted overhead track system) to provide a support for an incapacitated patient or a person with a disability that has been raised from a sitting position and held in a standing position for mobility training; it is primarily used for confidence building when walking. It is designed as a sling construction made of straps attached to a pants-like holder which is placed between the users' legs (the crotch) and secured high around the waist which will cradle the hip section of their body allowing them to maintain balance whilst moving slowly forward using their feet. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
423632996
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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

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05056387401850Silvalea Boned Back Stand aid poly loops MEDIUM202GM2025-03-13
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05056387439433Rachel Harness Mesh Navy XXSmallM921535-XXS2024-08-05
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05056387439457Rachel Harness Mesh Navy SmallM921535-S2024-08-05
05056387439464Rachel Harness Mesh Navy MediumM921535-M2024-08-05
05056387439471Rachel Harness Mesh Navy LargeM921535-L2024-08-05
05056387439488Rachel Harness Mesh Navy Extra LargeM921535-XL2024-08-05
05056387439495In-Situ Deluxe Superfine Double Layer XXXSmallM921536-XXXS2024-08-05
05056387439501In-Situ Deluxe Superfine Double Layer XXSmallM921536-XXS2024-08-05
05056387439518In-Situ Deluxe Superfine Double Layer Extra SmallM921536-XS2024-08-05
05056387439525In-Situ Deluxe Superfine Double Layer SmallM921536-S2024-08-05
05056387439532In-Situ Deluxe Superfine Double Layer MediumM921536-M2024-08-05
05056387439549In-Situ Deluxe Superfine Double Layer LargeM921536-L2024-08-05
05056387439556In-Situ Deluxe Superfine Double Layer Extra LargeM921536-XL2024-08-05
05056387439563Tinkham Sling Superfine Plus XXSmallM921537-XXS2024-08-05
05056387439570Tinkham Sling Superfine Plus Extra SmallM921537-XS2024-08-05
05056387439587Tinkham Sling Superfine Plus SmallM921537-S2024-08-05

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