FDA.report

Wellell

Primary DI
04719893351026
Company
Wellell Inc.
Model
9P-089000
Device description
VenAir, Sequential Compression System
Published
2026-03-17
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Regulatory Flags

DUNS number
656413127
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Identifiers

IdentifierTypeAgencyPackage quantityStatus
04719893351026PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
04719893351026PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
JOWSleeve, Limb, Compressible2Cardiovascular870.5800NEligible

Premarket Submissions

No records found.

Premarket Details

No records found.

GMDN Terms

TermDefinition
Sequential venous compression system inflatorAn electrically-powered device intended to be used for the noninvasive treatment and prevention of venous disorders/sequelae. As part of a compression system, the pump provides the connected stocking/sleeve/suit applied to the extremities with the necessary pressure to promote venous blood flow through its sequential inflation and deflation. Also referred to as a pump, it typically consists of a compressor with advanced control/timing mechanism, pressure limiting device, tubing, and connectors. The resulting increased venous blood flow may help to treat/prevent oedema, deep vein thrombosis (DVT) and pulmonary embolism (PE) in non-ambulatory patients or patients at risk.

Device Sizes

No records found.

Storage And Handling

No records found.

Sterilization Methods

Method

Contacts

No records found.

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04719893356922Wellell9P-0773712026-03-20
04719893347258WellellWiZARD 520 2026-03-17
04719893347265WellellWiZARD 5202026-03-17
04719893347272WellellWiZARD 5202026-03-17
04719893356540Wellell9P-0770002026-02-11
04719893355833Wellell9P-0485602025-09-19
04719893355857Wellell9P-0485602025-09-19
04719893355871Wellell 9P-0775202025-09-19
04719893355901Wellell9P-0470002025-09-19
04719893355925Wellell9P-0470002025-09-19
04719893355574Wellell9P-0485602025-08-13
04713025000820WellellWiZARD 5102025-05-28
04713025000837WellellWiZARD 5102025-05-28
04719893311877Wellell9P-0775202025-05-28
04719893311884Wellell9P-0770002025-05-28
04719893311945Wellell9P-0470002025-05-28
04719893311952Wellell9P-0470002025-05-28
04719893354331Wellell9P-0470002025-05-28
04719893354690Wellell9P-0790002025-05-21
04719893354713Wellell 9P-0775202025-05-21

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