LiteWalk Sandals

Primary DI
07290016880281
Brand
LiteWalk Sandals
Company
VIASONIX LTD
Model
Small
Catalog number
PVC0268-S
Device description
The LiteWalk pneumatic sandals [left/right] include 4 inflatable chambers that are located in the general regions of the heel, arch, metatarsals and toes. These chambers inflate sequentially to mimic the sequence of walking. The Small size is in : US 3-5, EU 35-38. The sandals are made of Colored Fabric Material. The sandals are supplied not sterile and for a reusable single patient use.
Published
2020-06-19
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
IRPMassager, Powered Inflatable Tube

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRPMassager, Powered Inflatable TubePhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192607000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192607000LiteWalkViasonix , Ltd.2019-12-19IRP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016880281PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016880281072900168802817290016880281

GMDN Terms#

Term, Definition table
TermDefinition
Sequential venous compression systemA system used for the noninvasive treatment and prevention of venous disorders and sequelae such as oedema, deep vein thrombosis (DVT) and pulmonary embolism (PE). It functions by applying sequential pressure to a patient's legs to promote venous blood flow. It consists of a compression pump, control/timing mechanism, tubing and has pneumatic stockings, sleeves, or a suit with several chambers that inflate and deflate sequentially in a pattern beginning at the foot or ankle and continuing to chambers around the calf and thigh. In some systems, each chamber reaches the same pressure but at different times, while others apply greater pressure distally which gradually diminishes higher up.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
533070236
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

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07290016880182Fingerclip PPG sensor Fingerclip PPG sensor 2020-06-19
07290016880250LiteWalkLiteWalk2020-06-19
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