FDA.reportPublic FDA data

Emerg Auto-Emersiontherapy

Primary DI
B627E10000
Brand
Emerg Auto-Emersiontherapy
Company
Auxilium Medical Inc.
Model
E1000
Catalog number
10008015
Device description
Emerg Auto-Emersiontherapy is a powered mattress replacement system that automatically customizes surface immersion specific to the patient's therapy needs, creating a fluid-like, pressure environment for wound healing.
Published
2026-11-01
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
IOQBed, Flotation Therapy, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IOQBed, Flotation Therapy, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B627E10000PrimaryHIBCC0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure00
Handling Environment Humidity00
Handling Environment Temperature00
Storage Environment Atmospheric Pressure00
Storage Environment Humidity00
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
8435614541info@auxiliummedical.com

Regulatory Flags#

DUNS number
115360019
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B627AF10000Resurg Air Fluidized Therapy SystemAF10001001043_2026-11-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08592654622094Multicare XL I N E T spol. s r.o.IOQ2026-10-06
00887761012172Centrella™ SurfaceHILL-ROM, INC.IOQ2026-08-03
00670482001125oneNEST MUmano Medical IncIOQ2026-07-31
00670482001132oneNEST MUmano Medical IncIOQ2026-07-31
08592654621790Multicare XL I N E T spol. s r.o.IOQ2026-07-17
00670482001019oneNEST MUmano Medical IncIOQ2026-04-24
00670482001026oneNEST MUmano Medical IncIOQ2026-04-24
00887761976870pro+HILL-ROM, INC.IOQ2026-04-21
00887761007536pro+HILL-ROM, INC.IOQ2026-04-20
00887761007543pro+HILL-ROM, INC.IOQ2026-04-20
00887761976863pro+HILL-ROM, INC.IOQ2026-04-20
00887761976887pro+HILL-ROM, INC.IOQ2026-04-20
00887761007666pro+HILL-ROM, INC.IOQ2026-03-27
00887761007697pro+HILL-ROM, INC.IOQ2026-03-27
00887761007703pro+HILL-ROM, INC.IOQ2026-03-27
00887761007505pro+HILL-ROM, INC.IOQ2026-03-25
00887761007512pro+HILL-ROM, INC.IOQ2026-03-25
00887761007550pro+HILL-ROM, INC.IOQ2026-03-25
00887761007567pro+HILL-ROM, INC.IOQ2026-03-25
00887761007581pro+HILL-ROM, INC.IOQ2026-03-25
00887761007598pro+HILL-ROM, INC.IOQ2026-03-25
00887761007604pro+HILL-ROM, INC.IOQ2026-03-25
00887761007611pro+HILL-ROM, INC.IOQ2026-03-25
00887761007628pro+HILL-ROM, INC.IOQ2026-03-25
00887761007635pro+HILL-ROM, INC.IOQ2026-03-25
00887761007642pro+HILL-ROM, INC.IOQ2026-03-25
00887761007659pro+HILL-ROM, INC.IOQ2026-03-25
08592654562703Multicare XL I N E T spol. s r.o.IOQ2026-01-07
08592654550441MulticareL I N E T spol. s r.o.IOQ2025-12-22
08592654510407MulticareL I N E T spol. s r.o.IOQ2025-05-26