FDA.report

Wellell

Primary DI
04719893355574
Company
Wellell Inc.
Model
9P-048560
Device description
Sedens 500
Published
2025-08-13
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
true
Sterilization required before use
false

Identifiers

IdentifierTypeAgencyPackage quantityStatus
04719893355574PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
04719893355574PrimaryGS10

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 chair cushion systemAn assembly of devices consisting of an alternating-pressure chair cushion and a dedicated pump, which also functions as the control unit, designed to actively change an occupant's buttocks-chair contact points, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized patients 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
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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
04719893356922WellellWellell Inc.FNM2026-03-20
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00860013391010ThinAIRTHIN AIR SURFACES, LLCFNM2026-03-10
00860013391027ThinAIRTHIN AIR SURFACES, LLCFNM2026-03-10
00860013391034ThinAIRTHIN AIR SURFACES, LLCFNM2026-03-10
00860013391041ThinAIRTHIN AIR SURFACES, LLCFNM2026-03-10
00810178887040ViveVIVE HEALTH LLCFNM2026-03-06
00810178887057ViveVIVE HEALTH LLCFNM2026-03-06
H93392270Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.FNM2026-02-25
04719893356540WellellWellell Inc.FNM2026-02-11
00810178884193ViveVIVE HEALTH LLCFNM2026-02-02
00810178884483ViveVIVE HEALTH LLCFNM2026-01-30
05059441536024AtmosAir VelarisArjohuntleigh ABFNM2026-01-15
05059441536031AtmosAir VelarisArjohuntleigh ABFNM2026-01-15
05059441536048AtmosAir VelarisArjohuntleigh ABFNM2026-01-15
05059441536055AtmosAir VelarisArjohuntleigh ABFNM2026-01-15
05059441536062AtmosAir VelarisArjohuntleigh ABFNM2026-01-15
05059441536079AtmosAir VelarisArjohuntleigh ABFNM2026-01-15
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04719873698615NACARILEX MEDICAL, INC.FNM2025-12-22
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14719873698636NACARILEX MEDICAL, INC.FNM2025-12-22
05061105057455Protekt VX 5000PROACTIVE MEDICAL PRODUCTS, LLCFNM2025-12-18
10193489148305MEDLINEMEDLINE INDUSTRIES, INC.FNM2025-12-12
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10197344172856MEDLINEMEDLINE INDUSTRIES, INC.FNM2025-12-12