FDA.reportPublic FDA data

InhwRior

Primary DI
06978785665100
Brand
InhwRior
Company
Shenzhen Yuechuan trade Co., Ltd.
Model
RCD
Device description
By utilizing cyclic alternating air inflation and deflation technology, it aims to alleviate localized pressure on the body’s contact areas with the mattress, improve blood circulation in pressured tissues, prevent the formation and progression of pressure ulcers (bedsores), and enhance overall lying comfort during long-term bed confinement.
Published
2025-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FNMMattress, Air Flotation, Alternating Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNMMattress, Air Flotation, Alternating PressureGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06978785665100PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06978785665100069787856651006978785665100

GMDN Terms#

Term, Definition table
TermDefinition
Alternating-pressure bed mattress systemAn assembly of devices consisting of an alternating-pressure bed mattress (inflation-patterned air cells with or without foam component) and a dedicated electric 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
450549961
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06978785665070InhwRiorZJNJ2025-12-08
06978785665087InhwRiorJGYJZQ-022025-12-08
06978785665094InhwRiorJGYJZQ-032025-12-08
06978785665117InhwRiorXBY2025-12-08
06978785665124InhwRiorXBY2025-12-08
06978785665131InhwRiorJQ-S14U-XBY2025-12-08
06978785665148InhwRiorJQ-CO9-XBY2025-12-08
06978785665056InhwRiorJQ-C092025-08-08
06978785665063InhwRiorJQ-S14U2025-08-08
26978785665043InhwRiorYC-ZJBHL-0042025-07-09
06978785665018InhwRiorYC-CDCJ-0012025-07-09
06978785665025InhwRiorYC-FZJZQ-0022025-07-09
06978785665032InhwRiorYC-JGYJZQ-0032025-07-09
16978785665046InhwRiorYC-ZJBHL-0042025-07-09
06978785665049InhwRiorYC-ZJBHL-0042025-07-09

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