FDA.report

VRED

Primary DI
00840390717047
Brand
VRED
Company
Legs 4 Life, LLC
Model
1
Catalog number
VREDFOAM LARGE
Device description
Venous Relief Elevation Device Foam VRED Large Foam
Published
2023-12-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
IKYMattress, Flotation Therapy, Non-Powered

Product Code Classifications

CodeDeviceSpecialtyClass
IKYMattress, Flotation Therapy, Non-PoweredGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840390717047PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840390717047008403907170478403907170470840390717047

GMDN Terms

TermDefinition
Multifunction body cushionA soft pillow or pad designed to provide support and comfort to a user's body part(s) in a variety of locations and positions, or to assist the user to fulfill a functional requirement involving various body parts. The device can be designed in a number of configurations that include a combined armrest-back support device, or an adjustable device.

Sterilization Methods

Method

Contacts

PhoneEmail
(804)640-7716rzell@ameswalker.com

Regulatory Flags

DUNS number
011882358
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00840390718525Ames Walker1707-S-BEIGE2026-02-17
00840390718532Ames Walker1707-M-BEIGE2026-02-17
00840390718549Ames Walker1707-L-BEIGE2026-02-17
00840390718556Ames Walker1707-XL-BEIGE2026-02-17
00840390718563Ames Walker1705-S-BEIGE2026-02-17
00840390718570Ames Walker1705-M-BEIGE2026-02-17
00840390718587Ames Walker1705-L-BEIGE2026-02-17
00840390718594Ames Walker1705-XL-BEIGE2026-02-17
00840390718600Ames Walker1100-XXL-BLACK2026-02-17
00840390718617Ames Walker141-S-BEIGE2026-02-17
00840390718624Ames Walker141-XXL-BEIGE2026-02-17
00840390718631Ames Walker118-XXL-BEIGE2026-02-17
00840390718648Ames Walker118 S LT.BEIGE2026-02-17
00840390718655Ames Walker118 M LT.BEIGE2026-02-17
00840390718662Ames Walker118 L LT.BEIGE2026-02-17
00840390718679Ames Walker118 XL LT.BEIGE2026-02-17
00840390718686Ames Walker1720-S-BLACK2026-02-17
00840390718693Ames Walker1720-M-BLACK2026-02-17
00840390718709Ames Walker1720-L-BLACK2026-02-17
00840390718716Ames Walker1720-XL-BLACK2026-02-17

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00887761010918Stretcher SurfaceHILL-ROM, INC.IKY2026-02-19
00887761010925Stretcher SurfaceHILL-ROM, INC.IKY2026-02-19
05059441461654TherarestArjohuntleigh ABIKY2026-02-10
00810178885084ViveVIVE HEALTH LLCIKY2026-02-02
00810178885091ViveVIVE HEALTH LLCIKY2026-02-02
H93353893Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-12-01
H93313584Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-09-04
H93335834Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-08-04
H93338296Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-08-04
00841447115151Invacare Solace MattressINVACARE CORPORATIONIKY2025-06-30
00841447115137Invacare Solace MattressINVACARE CORPORATIONIKY2025-06-23
H933MX8435NZ29Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-04-22
H933PR8036RP29Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-04-22
H933PR8436RP29Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-04-22
H933PR8436FP29Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-03-12
H933PR8036FP29Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-02-07
00840828193887BED MAT-7X36X88-CEN CORE-FOAM-PCCURBELL MEDICAL PRODUCTS, INC.IKY2025-01-08
00840828193894BED MAT-7X36X88-CENPROAF-PCCURBELL MEDICAL PRODUCTS, INC.IKY2025-01-08
H933UMX884829Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2024-12-03
00092237616246MERIDIAN MEDICALCOMPASS HEALTH BRANDS CORP.IKY2024-08-16
H93334371Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2024-08-13
00887761995116PROGRESSA+ ESSENTIAL SURFACEHill-Rom de México, S. de R.L. de C.V.IKY2024-07-12
00815067072941PROBASICSCOMPASS HEALTH BRANDS CORP.IKY2024-06-25
00841447114826Invacare EssentialsINVACARE CORPORATIONIKY2024-06-03
00841447114833Invacare EssentialsINVACARE CORPORATIONIKY2024-06-03
00841447114840Invacare EssentialsINVACARE CORPORATIONIKY2024-06-03
00841447114857Invacare EssentialsINVACARE CORPORATIONIKY2024-06-03
H933A803529B0Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2024-06-03
H933A804229B0Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2024-06-03