FDA.reportPublic FDA data

Immersus

Primary DI
00850016369062
Brand
Immersus
Company
IMMERSUS HEALTH COMPANY, LLC
Model
"Mattress 42""x80""x6"""
Catalog number
2247
Device description
"2247 Immersus Mattress 42""x80""x6"""
Published
2020-02-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IKYMattress, Flotation Therapy, Non-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKYMattress, Flotation Therapy, Non-PoweredGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850016369062PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850016369062008500163690628500163690620850016369062

GMDN Terms#

Term, Definition table
TermDefinition
Foam bed mattressA large, durable, fabric case filled with foam, which may be segmented/compartmentalised, designed to be placed on a bed mattress support platform to provide a comfortable surface on which an occupant can lie, rest, and sleep, and intended to distribute body weight over a large surface area typically to help relieve pressure points for comfort and improve blood circulation to prevent pressure sores. It may contain weight-distribution air cells. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080627691
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850016369437Posture-Mate"HB 16"" System Complete"22212020-02-20
00850016369444Posture-Mate"HB 18"" System Complete"22252020-02-20
00850016369451Posture-Mate"HB 20"" System Complete"22292020-02-20
00850016369468Posture-Mate"HB 22"" System Complete"22332020-02-20
00850016369475Posture-Mate"WC 16"" System Complete"22372020-02-20
00850016369482Posture-Mate"WC 18"" System Complete"22382020-02-20
00850016369499Posture-Mate"WC 20"" System Complete"22392020-02-20
00850016369505Posture-Mate"WC 22"" System Complete"22402020-02-20
00850016369512Posture-MateG System Complete22172020-02-20
00850016369529Posture-MateG Seat & Calf Assembly only2217-SC2020-02-20
00850016369536Posture-MateG Universal Arm Pad only2217-A2020-02-20
00850016369543Posture-MateG Back & Head Pillow Assembly only2217-BH2020-02-20
00850016369550Posture-Mate"WC 22"" Seat Cushion only"2244-S2020-02-20
00850016369567Posture-Mate"WC 22"" Back Cushion only"2244-B2020-02-20
00850016369574Posture-Mate"WC 22"" Calf Pad only"2244-C2020-02-20
00850016369581Posture-Mate"WC 20"" Seat Cushion only"2242-S2020-02-20
00850016369598Posture-Mate"WC 20"" Back Cushion only"2243-B2020-02-20
00850016369604Posture-Mate"WC 20"" Calf Pad only"2243-C2020-02-20
00850016369611Posture-Mate"HB 16"" Head Cushion only"2218-H2020-02-20
00850016369628Posture-Mate"HB 18"" Head Cushion only"2222-H2020-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00887761010901Stretcher SurfaceHILL-ROM, INC.IKY2026-02-19
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
08592654851067Ergozone 3000L I N E T spol. s r.o.IKY2025-11-03
08592654851074Ergozone 3000L I N E T spol. s r.o.IKY2025-11-03
08592654851081Ergozone 3000L I N E T spol. s r.o.IKY2025-11-03
00841447115175Invacare® Softform Premier Foam MattressINVACARE CORPORATIONIKY2025-10-10
00841447115182Invacare® Softform Premier Foam MattressINVACARE CORPORATIONIKY2025-10-10
00841447115199Invacare® Softform Premier Foam MattressINVACARE CORPORATIONIKY2025-10-10
00841447115205Invacare® Softform Premier Foam MattressINVACARE CORPORATIONIKY2025-10-10
05056147701497Accora Allevia ComfortACCORA LIMITEDIKY2025-09-30
05056147701503Accora Allevia ComfortACCORA LIMITEDIKY2025-09-30
05056147701510Accora Allevia ComfortACCORA LIMITEDIKY2025-09-30
05056147701527Accora Allevia ComfortACCORA LIMITEDIKY2025-09-30
05056147701534Accora Allevia PrimaACCORA LIMITEDIKY2025-09-30
05056147701541Accora Allevia PrimaACCORA LIMITEDIKY2025-09-30
05056147701558Accora Allevia PrimaACCORA LIMITEDIKY2025-09-30
05056147701565Accora Allevia PrimaACCORA LIMITEDIKY2025-09-30
05056147701572Accora Allevia ClassicACCORA LIMITEDIKY2025-09-30
05056147701589Accora Allevia ClassicACCORA LIMITEDIKY2025-09-30
05056147701596Accora Allevia ClassicACCORA LIMITEDIKY2025-09-30
05056147701602Accora Allevia ClassicACCORA LIMITEDIKY2025-09-30
H93331629Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-09-04
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