FDA.report

Wellell

Primary DI
04719893311945
Company
Wellell Inc.
Model
9P-047000
Device description
DOMUS 1 Pump and Mattress
Published
2025-05-28
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

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
false
Sterilization required before use
false

Identifiers

IdentifierTypeAgencyPackage quantityStatus
04719893311945PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
04719893311945PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
FNMMattress, Air Flotation, Alternating Pressure2General Hospital880.5550NEligible

Premarket Submissions

No records found.

Premarket Details

No records found.

GMDN Terms

TermDefinition
Alternating-pressure bed mattress overlay systemAn assembly of devices consisting of an alternating-pressure bed mattress overlay and a dedicated pump, which also functions as the control unit, designed to actively alternate a bed occupant's bed-contact points, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized (especially in cases of decubitus ulcers), patients with disabilities, or patients with low body fat.

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
04719893351026Wellell9P-0890002026-03-17
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
04719893311952Wellell9P-0470002025-05-28
04719893354331Wellell9P-0470002025-05-28
04719893354690Wellell9P-0790002025-05-21
04719893354713Wellell 9P-0775202025-05-21

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